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CANCER EVIDENCE

FDA source notices.

Approval notifications and safety communications preserved with their dates and original source text.

This is a captured collection, not a complete or live list of approvals. A notification must be read for its exact indication, population and regimen; it is not a recommendation.

Safety communications

2026-02-05 · Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency
id
fda-b2a4254ca443dc00
event type
fda_safety_labeling_notification
event date
2026-02-05
title
Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency
drug or regimen
capecitabine and fluorouracil (5-FU)
approval date
Source null
approval type
Source null
approval type evidence
Not applicable: safety communication.
indication summary
FDA safety-labeling communication concerning DPD deficiency and capecitabine/fluorouracil; see exact notice text. No new oncology indication is asserted.
indication source text
The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.
opening context blocks
  1. The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.
  2. The DPYD gene encodes the enzyme DPD, which breaks down >80% of fluorouracil. Patients with certain homozygous or compound heterozygous variants in the DPYD gene, known to result in complete or near complete absence of DPD activity (complete DPD deficiency), are at increased risk for acute early-onset toxicity and serious, including fatal, adverse reactions (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity) when exposed to capecitabine or fluorouracil. Patients with partial DPD activity (partial DPD deficiency) may also have an increased risk of serious, including fatal, adverse reactions.
  3. The FDA recently approved revisions to the Xeloda (capecitabine) and 5-FU product labeling to provide further information on DPD deficiency. The following summarizes the key changes that were made to the labeling of both drugs:
  4. Boxed Warning: The Boxed Warning now highlights the risk of serious adverse reactions or death in patients with complete DPD deficiency. It also advises DPYD testing prior to initiating capecitabine or 5-FU, unless immediate treatment is necessary, and recommends avoiding use in patients with certain homozygous or compound heterozygous DYPD variants that result in complete DPD deficiency.
  5. Dosage and Administration: A new subsection, 2.1 Evaluation and Testing for DPD Deficiency Before Initiating capecitabine or 5-FU, has been added and instructs to avoid use of these drugs in patients known to have certain homozygous or compound heterozygous DYPD variants that result in complete DPD deficiency. For patients with partial DPD deficiency, dosing should be individualized.
  6. Warnings and Precautions: Reiterates that prior to initiating capecitabine or 5-FU, patients should be tested for genetic variants of the DPYD gene unless immediate treatment is necessary.
  7. Content current as of: 02/05/2026
tumor type mapping hints
    mapping status
    heuristic_requires_editorial_review
    regulatory meaning
    Safety communication, not a new drug/indication approval.
    source url
    https://www.fda.gov/drugs/resources-information-approved-drugs/safety-labeling-update-capecitabine-and-fluorouracil-5-fu-risks-associated-dihydropyrimidine
    evidence source url
    https://www.fda.gov/drugs/resources-information-approved-drugs/safety-labeling-update-capecitabine-and-fluorouracil-5-fu-risks-associated-dihydropyrimidine
    source basis
    individual FDA notification page
    source locator
    Page title and opening approval paragraph; exact text and additional introductory blocks preserved
    index date
    2026-02-05
    index description
    The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.
    provenance
    retrieved at
    2026-09-09T23:21:45.913717+00:00
    local html
    pages/safety-labeling-update-capecitabine-and-fluorouracil-5-fu-risks-associated-dihydropyrimidine.html
    sha256
    5b7895ac1320a581416fe9af93b473d7e0679ab5b90d0204a6c6a1eff29aa90a
    headers file
    pages/safety-labeling-update-capecitabine-and-fluorouracil-5-fu-risks-associated-dihydropyrimidine.headers.txt
    full text file
    pages/safety-labeling-update-capecitabine-and-fluorouracil-5-fu-risks-associated-dihydropyrimidine.txt
    linked prescribing information
    nct ids
      quality flags
      1. safety_notice_not_approval_event
      2. tumor_mapping_unresolved
      verification status
      source_extracted_not_clinically_reviewed
      2025-01-24 · Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment
      id
      fda-e4f57941f6e52243
      event type
      fda_safety_labeling_notification
      event date
      2025-01-24
      title
      Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment
      drug or regimen
      capecitabine and fluorouracil (5-FU)
      approval date
      Source null
      approval type
      Source null
      approval type evidence
      Not applicable: safety communication.
      indication summary
      FDA safety-labeling communication concerning DPD deficiency and capecitabine/fluorouracil; see exact notice text. No new oncology indication is asserted.
      indication source text
      The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and discuss testing options for DPD deficiency with their patients.
      opening context blocks
      1. The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and discuss testing options for DPD deficiency with their patients.
      2. Fluoropyrimidines are a class of anti-cancer drugs that include fluorouracil (5-FU) and capecitabine, a prodrug of 5-FU. The DPYD gene encodes the enzyme DPD, which breaks down >80% of fluorouracil. Patients with certain homozygous or compound heterozygous variants in the DPYD gene, known to result in complete or near complete absence of DPD activity (complete DPD deficiency), are at increased risk for acute early-onset toxicity and serious, including fatal, adverse reactions (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity). Patients with partial DPD activity (partial DPD deficiency) may also have increased risk of serious, including fatal, adverse reactions.
      tumor type mapping hints
        mapping status
        heuristic_requires_editorial_review
        regulatory meaning
        Safety communication, not a new drug/indication approval.
        source url
        https://www.fda.gov/drugs/resources-information-approved-drugs/safety-announcement-fda-highlights-importance-dpd-deficiency-discussions-patients-prior-capecitabine
        evidence source url
        https://www.fda.gov/drugs/resources-information-approved-drugs/safety-announcement-fda-highlights-importance-dpd-deficiency-discussions-patients-prior-capecitabine
        source basis
        individual FDA notification page
        source locator
        Page title and opening approval paragraph; exact text and additional introductory blocks preserved
        index date
        2025-01-24
        index description
        The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and discuss testing options for DPD deficiency with their patients.
        provenance
        retrieved at
        2026-09-09T23:22:38.245389+00:00
        local html
        pages/safety-announcement-fda-highlights-importance-dpd-deficiency-discussions-patients-prior-capecitabine.html
        sha256
        d24341b52efcef798dc2eef9391dea7ca50aaa03f8ab91530619eabcc3c072b5
        headers file
        pages/safety-announcement-fda-highlights-importance-dpd-deficiency-discussions-patients-prior-capecitabine.headers.txt
        full text file
        pages/safety-announcement-fda-highlights-importance-dpd-deficiency-discussions-patients-prior-capecitabine.txt
        linked prescribing information
        nct ids
          quality flags
          1. safety_notice_not_approval_event
          2. tumor_mapping_unresolved
          verification status
          source_extracted_not_clinically_reviewed

          Oncology approval notifications

          2026-09-09 · FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer
          id
          fda-31fccf3ff6d99d7d
          event type
          fda_oncology_approval_notification
          event date
          2026-09-09
          title
          FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer
          drug or regimen
          sevabertinib
          approval date
          2026-09-09
          approval type
          accelerated
          approval type evidence
          accelerated explicitly stated in title/opening
          indication summary
          FDA approved sevabertinib, a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
          indication source text
          On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
          opening context blocks
          1. On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
          2. This approval expands the existing indication for sevabertinib, which was previously granted accelerated approval for adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations who had received prior systemic therapy.
          tumor type mapping hints
          1. lung
          mapping status
          heuristic_requires_editorial_review
          regulatory meaning
          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
          source url
          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small
          evidence source url
          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small
          source basis
          individual FDA notification page
          source locator
          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
          index date
          2026-09-09
          index description
          On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
          provenance
          retrieved at
          2026-09-09T23:21:12.769349+00:00
          local html
          pages/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small.html
          sha256
          b3e9681d45f18f76146ec5e619380b087a84b2aa21a2175366ccbf3eb3e7d464
          headers file
          pages/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small.headers.txt
          full text file
          pages/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small.txt
          linked prescribing information
            nct ids
            1. NCT05099172
            quality flags
            1. same_day_event_verify_label_availability
            verification status
            source_extracted_not_clinically_reviewed
            2026-09-04 · FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer
            id
            fda-29ff88a8fe51d0cc
            event type
            fda_oncology_approval_notification
            event date
            2026-09-04
            title
            FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancer
            drug or regimen
            camizestrant with a CDK4/6 inhibitor
            approval date
            2026-09-04
            approval type
            accelerated
            approval type evidence
            accelerated explicitly stated in title/opening
            indication summary
            FDA approved camizestrant, an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor for adults with hormone receptor -positive, human epidermal growth factor receptor 2 -negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
            indication source text
            On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
            opening context blocks
            1. On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
            2. FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with camizestrant.
            tumor type mapping hints
            1. breast
            mapping status
            heuristic_requires_editorial_review
            regulatory meaning
            Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
            source url
            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative
            evidence source url
            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative
            source basis
            individual FDA notification page
            source locator
            Page title and opening approval paragraph; exact text and additional introductory blocks preserved
            index date
            2026-09-04
            index description
            On September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
            provenance
            retrieved at
            2026-09-09T23:21:13.745390+00:00
            local html
            pages/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative.html
            sha256
            ed077cac42145668990b47a1c14d4d48dbf530e3958815fa7e19c144b8cf7344
            headers file
            pages/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative.headers.txt
            full text file
            pages/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative.txt
            linked prescribing information
              nct ids
              1. NCT04964934
              quality flags
                verification status
                source_extracted_not_clinically_reviewed
                2026-08-26 · FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma
                id
                fda-fc4a8b5bcf8bfd67
                event type
                fda_oncology_approval_notification
                event date
                2026-08-26
                title
                FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma
                drug or regimen
                daraxonrasib
                approval date
                2026-08-26
                approval type
                Source null
                approval type evidence
                FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                indication summary
                FDA approved daraxonrasib, an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
                indication source text
                On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
                opening context blocks
                1. On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
                tumor type mapping hints
                1. pancreatic
                mapping status
                heuristic_requires_editorial_review
                regulatory meaning
                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                source url
                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma
                evidence source url
                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma
                source basis
                individual FDA notification page
                source locator
                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                index date
                2026-08-26
                index description
                On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
                provenance
                retrieved at
                2026-09-09T23:21:14.778605+00:00
                local html
                pages/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma.html
                sha256
                03801106c1b52702d3d2e37194be9385c99fb3bd430f0bd422a6c0cc9f78084b
                headers file
                pages/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma.headers.txt
                full text file
                pages/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma.txt
                linked prescribing information
                  nct ids
                  1. NCT06625320
                  quality flags
                    verification status
                    source_extracted_not_clinically_reviewed
                    2026-08-25 · FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma
                    id
                    fda-6ffd9790ac8016fd
                    event type
                    fda_oncology_approval_notification
                    event date
                    2026-08-25
                    title
                    FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma
                    drug or regimen
                    zanidatamab-hrii and tislelizumab-jsgr
                    approval date
                    2026-08-25
                    approval type
                    Source null
                    approval type evidence
                    FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                    indication summary
                    Source null
                    indication source text
                    On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, and in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.: dolutegravir
                    opening context blocks
                      tumor type mapping hints
                      1. gastric
                      2. esophageal
                      mapping status
                      heuristic_requires_editorial_review
                      regulatory meaning
                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                      source url
                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction
                      evidence source url
                      https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications
                      source basis
                      FDA index only; linked page returned a soft 404
                      source locator
                      Index row
                      index date
                      2026-08-25
                      index description
                      On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, and in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.: dolutegravir
                      provenance
                      retrieved at
                      2026-09-09T23:21:15.918592+00:00
                      local html
                      pages/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction.html
                      sha256
                      300e265345b7a9b79dae3ef10d275ec350f491312afd401c696a18fc27d49071
                      headers file
                      pages/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction.headers.txt
                      full text file
                      pages/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction.txt
                      linked prescribing information
                        nct ids
                          quality flags
                          1. linked_page_soft_404
                          2. index_only_evidence_requires_review
                          3. index_text_contains_unrelated_drug_requires_source_reconciliation
                          verification status
                          source_extracted_not_clinically_reviewed
                          2026-08-13 · FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
                          id
                          fda-9b5c25c72ccbc4de
                          event type
                          fda_oncology_approval_notification
                          event date
                          2026-08-13
                          title
                          FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
                          drug or regimen
                          iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone
                          approval date
                          2026-08-13
                          approval type
                          accelerated
                          approval type evidence
                          accelerated explicitly stated in title/opening
                          indication summary
                          FDA approved iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
                          indication source text
                          On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
                          opening context blocks
                          1. On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
                          tumor type mapping hints
                          1. myeloma
                          mapping status
                          heuristic_requires_editorial_review
                          regulatory meaning
                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                          source url
                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone
                          evidence source url
                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone
                          source basis
                          individual FDA notification page
                          source locator
                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                          index date
                          2026-08-13
                          index description
                          On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
                          provenance
                          retrieved at
                          2026-09-09T23:21:16.713897+00:00
                          local html
                          pages/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone.html
                          sha256
                          3765fb83e794d5dbb9b4f41235f8d05e4d88e24abaf7b26adf9aa7cb999f7ceb
                          headers file
                          pages/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone.headers.txt
                          full text file
                          pages/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone.txt
                          linked prescribing information
                            nct ids
                            1. NCT04975997
                            quality flags
                              verification status
                              source_extracted_not_clinically_reviewed
                              2026-08-06 · FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma
                              id
                              fda-f02afa7b64e90adf
                              event type
                              fda_oncology_approval_notification
                              event date
                              2026-08-06
                              title
                              FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma
                              drug or regimen
                              vusolimogene oderparepvec-wtpg in combination with nivolumab
                              approval date
                              2026-08-06
                              approval type
                              accelerated
                              approval type evidence
                              accelerated explicitly stated in title/opening
                              indication summary
                              FDA approved vusolimogene oderparepvec-wtpg, a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 -blocking antibody-based regimen.
                              indication source text
                              On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
                              opening context blocks
                              1. On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
                              tumor type mapping hints
                              1. melanoma
                              mapping status
                              heuristic_requires_editorial_review
                              regulatory meaning
                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                              source url
                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma
                              evidence source url
                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma
                              source basis
                              individual FDA notification page
                              source locator
                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                              index date
                              2026-08-06
                              index description
                              On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
                              provenance
                              retrieved at
                              2026-09-09T23:21:17.711019+00:00
                              local html
                              pages/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma.html
                              sha256
                              270856cc39f6f788ebdcedaae211510eb83a5c823311d5cdf338089861728d77
                              headers file
                              pages/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma.headers.txt
                              full text file
                              pages/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma.txt
                              linked prescribing information
                                nct ids
                                1. NCT03767348
                                quality flags
                                  verification status
                                  source_extracted_not_clinically_reviewed
                                  2026-07-31 · FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
                                  id
                                  fda-036eff4becf1a0e2
                                  event type
                                  fda_oncology_approval_notification
                                  event date
                                  2026-07-31
                                  title
                                  FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
                                  drug or regimen
                                  lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy
                                  approval date
                                  2026-07-31
                                  approval type
                                  Source null
                                  approval type evidence
                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                  indication summary
                                  FDA approved lutetium Lu 177 vipivotide tetraxetan in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen -positive metastatic androgen pathway modulation-naïve or-sensitive prostate cancer .
                                  indication source text
                                  On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).
                                  opening context blocks
                                  1. On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).
                                  2. Patients with mAPMN/S prostate cancer should be selected for Pluvicto using Locametz (active ingredient gallium Ga 68 gozetotide) or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.
                                  tumor type mapping hints
                                  1. prostate
                                  mapping status
                                  heuristic_requires_editorial_review
                                  regulatory meaning
                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                  source url
                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy
                                  evidence source url
                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy
                                  source basis
                                  individual FDA notification page
                                  source locator
                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                  index date
                                  2026-07-31
                                  index description
                                  On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).
                                  provenance
                                  retrieved at
                                  2026-09-09T23:21:18.783041+00:00
                                  local html
                                  pages/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy.html
                                  sha256
                                  ab039def64e7aeead376ca6bde16cf5499da58c5c8b4e9cac718673ce52f6b2e
                                  headers file
                                  pages/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy.headers.txt
                                  full text file
                                  pages/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy.txt
                                  linked prescribing information
                                    nct ids
                                    1. NCT04720157
                                    quality flags
                                      verification status
                                      source_extracted_not_clinically_reviewed
                                      2026-07-22 · FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
                                      id
                                      fda-e0f74c6ff06b5fd4
                                      event type
                                      fda_oncology_approval_notification
                                      event date
                                      2026-07-22
                                      title
                                      FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
                                      drug or regimen
                                      zidesamtinib
                                      approval date
                                      2026-07-22
                                      approval type
                                      Source null
                                      approval type evidence
                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                      indication summary
                                      FDA approved zidesamtinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received at least one prior ROS1 tyrosine kinase inhibitor .
                                      indication source text
                                      On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).
                                      opening context blocks
                                      1. On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).
                                      tumor type mapping hints
                                      1. lung
                                      mapping status
                                      heuristic_requires_editorial_review
                                      regulatory meaning
                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                      source url
                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer
                                      evidence source url
                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer
                                      source basis
                                      individual FDA notification page
                                      source locator
                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                      index date
                                      2026-07-22
                                      index description
                                      On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).
                                      provenance
                                      retrieved at
                                      2026-09-09T23:21:19.730798+00:00
                                      local html
                                      pages/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer.html
                                      sha256
                                      f2958091d15d8c938233273c4eac75d7ef30a16e766187198637437e703263d3
                                      headers file
                                      pages/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer.headers.txt
                                      full text file
                                      pages/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer.txt
                                      linked prescribing information
                                        nct ids
                                        1. NCT05118789
                                        quality flags
                                          verification status
                                          source_extracted_not_clinically_reviewed
                                          2026-07-14 · FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
                                          id
                                          fda-d52a86815b17155d
                                          event type
                                          fda_oncology_approval_notification
                                          event date
                                          2026-07-14
                                          title
                                          FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
                                          drug or regimen
                                          selpercatinib
                                          approval date
                                          2026-07-14
                                          approval type
                                          traditional
                                          approval type evidence
                                          traditional explicitly stated in title/opening
                                          indication summary
                                          FDA approved selpercatinib for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Selpercatinib received accelerated approval for this indication for adult patients in 2022 and for pediatric patients two years of age and older in 2024.
                                          indication source text
                                          On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Selpercatinib received accelerated approval for this indication for adult patients in 2022 and for pediatric patients two years of age and older in 2024.
                                          opening context blocks
                                          1. On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Selpercatinib received accelerated approval for this indication for adult patients in 2022 and for pediatric patients two years of age and older in 2024.
                                          tumor type mapping hints
                                          1. solid-tumors
                                          mapping status
                                          heuristic_requires_editorial_review
                                          regulatory meaning
                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                          source url
                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive
                                          evidence source url
                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive
                                          source basis
                                          individual FDA notification page
                                          source locator
                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                          index date
                                          2026-07-14
                                          index description
                                          On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
                                          provenance
                                          retrieved at
                                          2026-09-09T23:21:21.811380+00:00
                                          local html
                                          pages/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive.html
                                          sha256
                                          a3d867d73cad805eb60451d11a66bf87cbb1a3a231528843da6339269c308c91
                                          headers file
                                          pages/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive.headers.txt
                                          full text file
                                          pages/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive.txt
                                          linked prescribing information
                                            nct ids
                                            1. NCT03157128
                                            2. NCT03899792
                                            quality flags
                                              verification status
                                              source_extracted_not_clinically_reviewed
                                              2026-07-14 · FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
                                              id
                                              fda-cfcc707359fdc22f
                                              event type
                                              fda_oncology_approval_notification
                                              event date
                                              2026-07-14
                                              title
                                              FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
                                              drug or regimen
                                              gedatolisib with fulvestrant, with or without palbociclib
                                              approval date
                                              2026-07-14
                                              approval type
                                              Source null
                                              approval type evidence
                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                              indication summary
                                              FDA approved gedatolisib in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor -positive, human epidermal growth factor receptor 2 -negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
                                              indication source text
                                              On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
                                              opening context blocks
                                              1. On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
                                              tumor type mapping hints
                                              1. breast
                                              mapping status
                                              heuristic_requires_editorial_review
                                              regulatory meaning
                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                              source url
                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally
                                              evidence source url
                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally
                                              source basis
                                              individual FDA notification page
                                              source locator
                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                              index date
                                              2026-07-14
                                              index description
                                              On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
                                              provenance
                                              retrieved at
                                              2026-09-09T23:21:20.912969+00:00
                                              local html
                                              pages/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally.html
                                              sha256
                                              74217a4030c1a9c546b3aa865934ded1ad916ef10f82fd36f714296469ba8ad2
                                              headers file
                                              pages/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally.headers.txt
                                              full text file
                                              pages/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally.txt
                                              linked prescribing information
                                                nct ids
                                                1. NCT05501886
                                                quality flags
                                                  verification status
                                                  source_extracted_not_clinically_reviewed
                                                  2026-07-10 · FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
                                                  id
                                                  fda-0403089146861ff3
                                                  event type
                                                  fda_oncology_approval_notification
                                                  event date
                                                  2026-07-10
                                                  title
                                                  FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
                                                  drug or regimen
                                                  pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv
                                                  approval date
                                                  2026-07-10
                                                  approval type
                                                  Source null
                                                  approval type evidence
                                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                  indication summary
                                                  FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each in combination with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer . This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.
                                                  indication source text
                                                  On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.
                                                  opening context blocks
                                                  1. On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.
                                                  tumor type mapping hints
                                                  1. bladder
                                                  mapping status
                                                  heuristic_requires_editorial_review
                                                  regulatory meaning
                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                  source url
                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin
                                                  evidence source url
                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin
                                                  source basis
                                                  individual FDA notification page
                                                  source locator
                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                  index date
                                                  2026-07-10
                                                  index description
                                                  On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.
                                                  provenance
                                                  retrieved at
                                                  2026-09-09T23:21:22.782079+00:00
                                                  local html
                                                  pages/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin.html
                                                  sha256
                                                  bf6f488e30803660b4becc73e3d78ddfb9b9998c42888f6e54a534c3b7eb1056
                                                  headers file
                                                  pages/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin.headers.txt
                                                  full text file
                                                  pages/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin.txt
                                                  linked prescribing information
                                                    nct ids
                                                    1. NCT04700124
                                                    quality flags
                                                      verification status
                                                      source_extracted_not_clinically_reviewed
                                                      2026-07-09 · FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
                                                      id
                                                      fda-99375b4186db616c
                                                      event type
                                                      fda_oncology_approval_notification
                                                      event date
                                                      2026-07-09
                                                      title
                                                      FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
                                                      drug or regimen
                                                      isatuximab-irfc
                                                      approval date
                                                      2026-07-09
                                                      approval type
                                                      Source null
                                                      approval type evidence
                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                      indication summary
                                                      FDA approved isatuximab-irfc for subcutaneous injection for multiple myeloma indications. The specific indications approved for Isatuximab-irfc are:
                                                      indication source text
                                                      On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications. The specific indications approved for Isatuximab-irfc are:
                                                      opening context blocks
                                                      1. On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications. The specific indications approved for Isatuximab-irfc are:
                                                      2. in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor,
                                                      3. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, and
                                                      4. in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant.
                                                      tumor type mapping hints
                                                      1. myeloma
                                                      mapping status
                                                      heuristic_requires_editorial_review
                                                      regulatory meaning
                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                      source url
                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications
                                                      evidence source url
                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications
                                                      source basis
                                                      individual FDA notification page
                                                      source locator
                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                      index date
                                                      2026-07-09
                                                      index description
                                                      On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.
                                                      provenance
                                                      retrieved at
                                                      2026-09-09T23:21:23.756613+00:00
                                                      local html
                                                      pages/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications.html
                                                      sha256
                                                      f9c3cc331a6c5c3c050b9be17d259cbe86270a3958a1200f88e6b39cc9c10877
                                                      headers file
                                                      pages/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications.headers.txt
                                                      full text file
                                                      pages/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications.txt
                                                      linked prescribing information
                                                        nct ids
                                                        1. NCT05405166
                                                        2. NCT05704049
                                                        3. NCT05889221
                                                        quality flags
                                                        1. possible_multiple_indications_review
                                                        verification status
                                                        source_extracted_not_clinically_reviewed
                                                        2026-06-30 · FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies
                                                        id
                                                        fda-960b36951050035f
                                                        event type
                                                        fda_oncology_approval_notification
                                                        event date
                                                        2026-06-30
                                                        title
                                                        FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies
                                                        drug or regimen
                                                        allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq
                                                        approval date
                                                        2026-06-30
                                                        approval type
                                                        Source null
                                                        approval type evidence
                                                        FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                        indication summary
                                                        FDA approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell and T cells-vldq for use in matched donor hematopoietic stem cell transplantation with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease -free survival, in the treatment of adults with hematological malignancies.
                                                        indication source text
                                                        On June 30, 2026, the Food and Drug Administration approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free survival, in the treatment of adults with hematological malignancies.
                                                        opening context blocks
                                                        1. On June 30, 2026, the Food and Drug Administration approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free survival, in the treatment of adults with hematological malignancies.
                                                        tumor type mapping hints
                                                        1. hematologic-malignancies
                                                        2. graft-versus-host-disease
                                                        mapping status
                                                        heuristic_requires_editorial_review
                                                        regulatory meaning
                                                        Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                        source url
                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched
                                                        evidence source url
                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched
                                                        source basis
                                                        individual FDA notification page
                                                        source locator
                                                        Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                        index date
                                                        2026-06-30
                                                        index description
                                                        On June 30, 2026, the Food and Drug Administration approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free survival, in the treatment of adults with hematological malignancies.
                                                        provenance
                                                        retrieved at
                                                        2026-09-09T23:21:24.817655+00:00
                                                        local html
                                                        pages/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched.html
                                                        sha256
                                                        eb0296d3fe55cb306eb68827d48a5c43ba30dee17d2bc6634ec89797585f8038
                                                        headers file
                                                        pages/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched.headers.txt
                                                        full text file
                                                        pages/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched.txt
                                                        linked prescribing information
                                                          nct ids
                                                          1. NCT05316701
                                                          quality flags
                                                          1. may_be_supportive_care_or_nonmalignant_condition
                                                          verification status
                                                          source_extracted_not_clinically_reviewed
                                                          2026-06-24 · FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer
                                                          id
                                                          fda-679b968656ef28cf
                                                          event type
                                                          fda_oncology_approval_notification
                                                          event date
                                                          2026-06-24
                                                          title
                                                          FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer
                                                          drug or regimen
                                                          palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy
                                                          approval date
                                                          2026-06-24
                                                          approval type
                                                          Source null
                                                          approval type evidence
                                                          FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                          indication summary
                                                          FDA approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
                                                          indication source text
                                                          On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
                                                          opening context blocks
                                                          1. On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
                                                          tumor type mapping hints
                                                          1. breast
                                                          mapping status
                                                          heuristic_requires_editorial_review
                                                          regulatory meaning
                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                          source url
                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance
                                                          evidence source url
                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance
                                                          source basis
                                                          individual FDA notification page
                                                          source locator
                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                          index date
                                                          2026-06-24
                                                          index description
                                                          On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
                                                          provenance
                                                          retrieved at
                                                          2026-09-09T23:21:26.823267+00:00
                                                          local html
                                                          pages/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance.html
                                                          sha256
                                                          4d48b127454b29f07f061828b9b9e9144f885c5627ada3525fa505a0023cadf5
                                                          headers file
                                                          pages/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance.headers.txt
                                                          full text file
                                                          pages/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance.txt
                                                          linked prescribing information
                                                            nct ids
                                                            1. NCT02947685
                                                            quality flags
                                                              verification status
                                                              source_extracted_not_clinically_reviewed
                                                              2026-06-24 · FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
                                                              id
                                                              fda-49e2a73345425f2f
                                                              event type
                                                              fda_oncology_approval_notification
                                                              event date
                                                              2026-06-24
                                                              title
                                                              FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
                                                              drug or regimen
                                                              sacituzumab govitecan-hziy
                                                              approval date
                                                              2026-06-24
                                                              approval type
                                                              Source null
                                                              approval type evidence
                                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                              indication summary
                                                              FDA approved sacituzumab govitecan-hziy for two indications in adults with triple-negative breast cancer . The first indication, supported by ASCENT-03, is for sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. The second indication, supported by ASCENT-04/KEYNOTE D-19, is for sacituzumab govitecan-hziy in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 as determined by an FDA-authorized test.
                                                              indication source text
                                                              On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC). The first indication, supported by ASCENT-03, is for sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. The second indication, supported by ASCENT-04/KEYNOTE D-19, is for sacituzumab govitecan-hziy in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test.
                                                              opening context blocks
                                                              1. On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC). The first indication, supported by ASCENT-03, is for sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. The second indication, supported by ASCENT-04/KEYNOTE D-19, is for sacituzumab govitecan-hziy in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test.
                                                              tumor type mapping hints
                                                              1. breast
                                                              mapping status
                                                              heuristic_requires_editorial_review
                                                              regulatory meaning
                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                              source url
                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line
                                                              evidence source url
                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line
                                                              source basis
                                                              individual FDA notification page
                                                              source locator
                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                              index date
                                                              2026-06-24
                                                              index description
                                                              On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC).
                                                              provenance
                                                              retrieved at
                                                              2026-09-09T23:21:25.821426+00:00
                                                              local html
                                                              pages/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line.html
                                                              sha256
                                                              bb697716c4548303a503ab4e49e2734a6077549e273126e0ca61097049ad1556
                                                              headers file
                                                              pages/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line.headers.txt
                                                              full text file
                                                              pages/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line.txt
                                                              linked prescribing information
                                                                nct ids
                                                                1. NCT05382286
                                                                2. NCT05382299
                                                                quality flags
                                                                1. possible_multiple_indications_review
                                                                verification status
                                                                source_extracted_not_clinically_reviewed
                                                                2026-06-12 · FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
                                                                id
                                                                fda-b7661f27f59bbecb
                                                                event type
                                                                fda_oncology_approval_notification
                                                                event date
                                                                2026-06-12
                                                                title
                                                                FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
                                                                drug or regimen
                                                                capivasertib with abiraterone and prednisone
                                                                approval date
                                                                2026-06-12
                                                                approval type
                                                                Source null
                                                                approval type evidence
                                                                FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                indication summary
                                                                FDA approved capivasertib in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.
                                                                indication source text
                                                                On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.
                                                                opening context blocks
                                                                1. On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.
                                                                2. The FDA also approved the VENTANA PTEN (SP218) RxDx Assay (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to identify patients with PTEN-deficient prostate cancer for treatment with capivasertib.
                                                                tumor type mapping hints
                                                                1. prostate
                                                                mapping status
                                                                heuristic_requires_editorial_review
                                                                regulatory meaning
                                                                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                source url
                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation
                                                                evidence source url
                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation
                                                                source basis
                                                                individual FDA notification page
                                                                source locator
                                                                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                index date
                                                                2026-06-12
                                                                index description
                                                                On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.
                                                                provenance
                                                                retrieved at
                                                                2026-09-09T23:21:27.956820+00:00
                                                                local html
                                                                pages/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation.html
                                                                sha256
                                                                f35d1e46ad48c7c60d04bccc44192fbba54f0da944513b3fa1c65803b306df7d
                                                                headers file
                                                                pages/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation.headers.txt
                                                                full text file
                                                                pages/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation.txt
                                                                linked prescribing information
                                                                  nct ids
                                                                  1. NCT04305496
                                                                  quality flags
                                                                    verification status
                                                                    source_extracted_not_clinically_reviewed
                                                                    2026-06-12 · FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
                                                                    id
                                                                    fda-69399853a62eefe0
                                                                    event type
                                                                    fda_oncology_approval_notification
                                                                    event date
                                                                    2026-06-12
                                                                    title
                                                                    FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
                                                                    drug or regimen
                                                                    belzutifan with pembrolizumab
                                                                    approval date
                                                                    2026-06-12
                                                                    approval type
                                                                    Source null
                                                                    approval type evidence
                                                                    FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                    indication summary
                                                                    FDA approved belzutifan in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                    indication source text
                                                                    On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                    opening context blocks
                                                                    1. On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                    tumor type mapping hints
                                                                    1. kidney
                                                                    mapping status
                                                                    heuristic_requires_editorial_review
                                                                    regulatory meaning
                                                                    Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                    source url
                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma
                                                                    evidence source url
                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma
                                                                    source basis
                                                                    individual FDA notification page
                                                                    source locator
                                                                    Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                    index date
                                                                    2026-06-12
                                                                    index description
                                                                    On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                    provenance
                                                                    retrieved at
                                                                    2026-09-09T23:21:28.765163+00:00
                                                                    local html
                                                                    pages/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma.html
                                                                    sha256
                                                                    28ece2fdf0101dcb6b831615d98c6193c4369a5ac9af9b449ee64e5bb6f154b2
                                                                    headers file
                                                                    pages/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma.headers.txt
                                                                    full text file
                                                                    pages/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma.txt
                                                                    linked prescribing information
                                                                      nct ids
                                                                      1. NCT05239728
                                                                      quality flags
                                                                        verification status
                                                                        source_extracted_not_clinically_reviewed
                                                                        2026-05-28 · FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
                                                                        id
                                                                        fda-c07ece06c8530681
                                                                        event type
                                                                        fda_oncology_approval_notification
                                                                        event date
                                                                        2026-05-28
                                                                        title
                                                                        FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
                                                                        drug or regimen
                                                                        durvalumab in combination with Bacillus Calmette-Guerin
                                                                        approval date
                                                                        2026-05-28
                                                                        approval type
                                                                        Source null
                                                                        approval type evidence
                                                                        FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                        indication summary
                                                                        FDA approved durvalumab in combination with Bacillus Calmette-Guerin for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer .
                                                                        indication source text
                                                                        On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
                                                                        opening context blocks
                                                                        1. On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
                                                                        tumor type mapping hints
                                                                        1. bladder
                                                                        mapping status
                                                                        heuristic_requires_editorial_review
                                                                        regulatory meaning
                                                                        Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                        source url
                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder
                                                                        evidence source url
                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder
                                                                        source basis
                                                                        individual FDA notification page
                                                                        source locator
                                                                        Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                        index date
                                                                        2026-05-28
                                                                        index description
                                                                        On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
                                                                        provenance
                                                                        retrieved at
                                                                        2026-09-09T23:21:29.887505+00:00
                                                                        local html
                                                                        pages/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder.html
                                                                        sha256
                                                                        9f2c0dce4183fec53f6c4377349ee5575f19348614c3c6787e0155c597e34c17
                                                                        headers file
                                                                        pages/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder.headers.txt
                                                                        full text file
                                                                        pages/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder.txt
                                                                        linked prescribing information
                                                                          nct ids
                                                                          1. NCT03528694
                                                                          quality flags
                                                                            verification status
                                                                            source_extracted_not_clinically_reviewed
                                                                            2026-05-27 · FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy
                                                                            id
                                                                            fda-d96394837965add4
                                                                            event type
                                                                            fda_oncology_approval_notification
                                                                            event date
                                                                            2026-05-27
                                                                            title
                                                                            FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy
                                                                            drug or regimen
                                                                            pivekimab sunirine-pvzy
                                                                            approval date
                                                                            2026-05-27
                                                                            approval type
                                                                            Source null
                                                                            approval type evidence
                                                                            FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                            indication summary
                                                                            FDA approved pivekimab sunirine-pvzy, a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm .
                                                                            indication source text
                                                                            On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
                                                                            opening context blocks
                                                                            1. On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
                                                                            tumor type mapping hints
                                                                            1. bpdcn
                                                                            mapping status
                                                                            heuristic_requires_editorial_review
                                                                            regulatory meaning
                                                                            Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                            source url
                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare
                                                                            evidence source url
                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare
                                                                            source basis
                                                                            individual FDA notification page
                                                                            source locator
                                                                            Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                            index date
                                                                            2026-05-27
                                                                            index description
                                                                            On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
                                                                            provenance
                                                                            retrieved at
                                                                            2026-09-09T23:21:30.844120+00:00
                                                                            local html
                                                                            pages/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare.html
                                                                            sha256
                                                                            0259b35cb052669a5bd357dc962cb8335b9fa8e23abc49752141ec1b9f3c371d
                                                                            headers file
                                                                            pages/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare.headers.txt
                                                                            full text file
                                                                            pages/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare.txt
                                                                            linked prescribing information
                                                                              nct ids
                                                                              1. NCT03386513
                                                                              quality flags
                                                                                verification status
                                                                                source_extracted_not_clinically_reviewed
                                                                                2026-05-22 · FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
                                                                                id
                                                                                fda-06e75bbbea9cc2b5
                                                                                event type
                                                                                fda_oncology_approval_notification
                                                                                event date
                                                                                2026-05-22
                                                                                title
                                                                                FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
                                                                                drug or regimen
                                                                                datopotamab deruxtecan-dlnk
                                                                                approval date
                                                                                2026-05-22
                                                                                approval type
                                                                                Source null
                                                                                approval type evidence
                                                                                FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                indication summary
                                                                                FDA approved datopotamab deruxtecan-dlnk for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
                                                                                indication source text
                                                                                On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
                                                                                opening context blocks
                                                                                1. On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
                                                                                tumor type mapping hints
                                                                                1. breast
                                                                                mapping status
                                                                                heuristic_requires_editorial_review
                                                                                regulatory meaning
                                                                                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                source url
                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer
                                                                                evidence source url
                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer
                                                                                source basis
                                                                                individual FDA notification page
                                                                                source locator
                                                                                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                index date
                                                                                2026-05-22
                                                                                index description
                                                                                On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
                                                                                provenance
                                                                                retrieved at
                                                                                2026-09-09T23:21:31.836659+00:00
                                                                                local html
                                                                                pages/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer.html
                                                                                sha256
                                                                                cb99c6537f90d5fa344f69e223abca0894c4c05d6d04d7b99494fe3377142365
                                                                                headers file
                                                                                pages/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer.headers.txt
                                                                                full text file
                                                                                pages/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer.txt
                                                                                linked prescribing information
                                                                                  nct ids
                                                                                  1. NCT05374512
                                                                                  quality flags
                                                                                    verification status
                                                                                    source_extracted_not_clinically_reviewed
                                                                                    2026-05-15 · FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
                                                                                    id
                                                                                    fda-a25466af65cfcdc1
                                                                                    event type
                                                                                    fda_oncology_approval_notification
                                                                                    event date
                                                                                    2026-05-15
                                                                                    title
                                                                                    FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
                                                                                    drug or regimen
                                                                                    fam-trastuzumab deruxtecan-nxki
                                                                                    approval date
                                                                                    2026-05-15
                                                                                    approval type
                                                                                    Source null
                                                                                    approval type evidence
                                                                                    FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                    indication summary
                                                                                    FDA approved fam-trastuzumab deruxtecan-nxki for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab, for the neoadjuvant treatment of adult patients with HER2-positive Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab and taxane-based treatment.
                                                                                    indication source text
                                                                                    On May 15, 2026, the Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.
                                                                                    opening context blocks
                                                                                    1. On May 15, 2026, the Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.
                                                                                    2. FDA also approved two companion diagnostic devices, the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail, both for identifying HER2-positive (IHC3+ or ISH+) patients for treatment with T-DXd, consistent with the approved drug labeling.
                                                                                    tumor type mapping hints
                                                                                    1. breast
                                                                                    mapping status
                                                                                    heuristic_requires_editorial_review
                                                                                    regulatory meaning
                                                                                    Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                    source url
                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage
                                                                                    evidence source url
                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage
                                                                                    source basis
                                                                                    individual FDA notification page
                                                                                    source locator
                                                                                    Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                    index date
                                                                                    2026-05-15
                                                                                    index description
                                                                                    On May 15, 2026, the Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.
                                                                                    provenance
                                                                                    retrieved at
                                                                                    2026-09-09T23:21:32.859371+00:00
                                                                                    local html
                                                                                    pages/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage.html
                                                                                    sha256
                                                                                    aad49cf422484a3ebbae4763ae0464de8899292d956b2f72389b35cebdbafed8
                                                                                    headers file
                                                                                    pages/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage.headers.txt
                                                                                    full text file
                                                                                    pages/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage.txt
                                                                                    linked prescribing information
                                                                                      nct ids
                                                                                      1. NCT04622319
                                                                                      2. NCT05113251
                                                                                      quality flags
                                                                                      1. possible_multiple_indications_review
                                                                                      verification status
                                                                                      source_extracted_not_clinically_reviewed
                                                                                      2026-05-15 · FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease
                                                                                      id
                                                                                      fda-7f6ca1fc3c4ca109
                                                                                      event type
                                                                                      fda_oncology_approval_notification
                                                                                      event date
                                                                                      2026-05-15
                                                                                      title
                                                                                      FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease
                                                                                      drug or regimen
                                                                                      atezolizumab
                                                                                      approval date
                                                                                      2026-05-15
                                                                                      approval type
                                                                                      Source null
                                                                                      approval type evidence
                                                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                      indication summary
                                                                                      FDA approved atezolizumab and atezolizumab and hyaluronidase-tqjs as adjuvant treatments for adults with muscle invasive bladder cancer after cystectomy who have circulating tumor DNA molecular residual disease as determined by an FDA-authorized test.
                                                                                      indication source text
                                                                                      On May 15, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.
                                                                                      opening context blocks
                                                                                      1. On May 15, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.
                                                                                      2. Today, the FDA also approved Signatera CDx (Natera, Inc.) as a companion diagnostic device to select patients with MIBC after cystectomy who have ctDNA MRD for adjuvant treatment with Tecentriq or with Tecentriq Hybreza.
                                                                                      tumor type mapping hints
                                                                                      1. bladder
                                                                                      mapping status
                                                                                      heuristic_requires_editorial_review
                                                                                      regulatory meaning
                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                      source url
                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-muscle-invasive-bladder-cancer-patients-molecular
                                                                                      evidence source url
                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-adjuvant-treatment-muscle-invasive-bladder-cancer-patients-molecular
                                                                                      source basis
                                                                                      individual FDA notification page
                                                                                      source locator
                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                      index date
                                                                                      2026-05-15
                                                                                      index description
                                                                                      On May 15, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc. and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) as adjuvant treatments for adults with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test.
                                                                                      provenance
                                                                                      retrieved at
                                                                                      2026-09-09T23:21:33.865268+00:00
                                                                                      local html
                                                                                      pages/fda-approves-atezolizumab-adjuvant-treatment-muscle-invasive-bladder-cancer-patients-molecular.html
                                                                                      sha256
                                                                                      9d86d73badf89f759b209b6391649d04511a7244607a0530628462fc7bb8d3f0
                                                                                      headers file
                                                                                      pages/fda-approves-atezolizumab-adjuvant-treatment-muscle-invasive-bladder-cancer-patients-molecular.headers.txt
                                                                                      full text file
                                                                                      pages/fda-approves-atezolizumab-adjuvant-treatment-muscle-invasive-bladder-cancer-patients-molecular.txt
                                                                                      linked prescribing information
                                                                                        nct ids
                                                                                        1. NCT04660344
                                                                                        quality flags
                                                                                          verification status
                                                                                          source_extracted_not_clinically_reviewed
                                                                                          2026-05-13 · FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
                                                                                          id
                                                                                          fda-e3ca63e98a156ea8
                                                                                          event type
                                                                                          fda_oncology_approval_notification
                                                                                          event date
                                                                                          2026-05-13
                                                                                          title
                                                                                          FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
                                                                                          drug or regimen
                                                                                          sonrotoclax
                                                                                          approval date
                                                                                          2026-05-13
                                                                                          approval type
                                                                                          accelerated
                                                                                          approval type evidence
                                                                                          accelerated explicitly stated in title/opening
                                                                                          indication summary
                                                                                          FDA approved sonrotoclax, a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.
                                                                                          indication source text
                                                                                          On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
                                                                                          opening context blocks
                                                                                          1. On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
                                                                                          tumor type mapping hints
                                                                                          1. lymphoma
                                                                                          mapping status
                                                                                          heuristic_requires_editorial_review
                                                                                          regulatory meaning
                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                          source url
                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma
                                                                                          evidence source url
                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma
                                                                                          source basis
                                                                                          individual FDA notification page
                                                                                          source locator
                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                          index date
                                                                                          2026-05-13
                                                                                          index description
                                                                                          On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
                                                                                          provenance
                                                                                          retrieved at
                                                                                          2026-09-09T23:21:35.757057+00:00
                                                                                          local html
                                                                                          pages/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma.html
                                                                                          sha256
                                                                                          01b9299b0da05e4058a5455be3034626d2257dddea53bf155532d3893678a81c
                                                                                          headers file
                                                                                          pages/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma.headers.txt
                                                                                          full text file
                                                                                          pages/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma.txt
                                                                                          linked prescribing information
                                                                                            nct ids
                                                                                            1. NCT05471843
                                                                                            quality flags
                                                                                              verification status
                                                                                              source_extracted_not_clinically_reviewed
                                                                                              2026-05-13 · FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
                                                                                              id
                                                                                              fda-990c1df07ad6d6a2
                                                                                              event type
                                                                                              fda_oncology_approval_notification
                                                                                              event date
                                                                                              2026-05-13
                                                                                              title
                                                                                              FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
                                                                                              drug or regimen
                                                                                              oral combination of decitabine and cedazuridine tablets with venetoclax
                                                                                              approval date
                                                                                              2026-05-13
                                                                                              approval type
                                                                                              Source null
                                                                                              approval type evidence
                                                                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                              indication summary
                                                                                              FDA approved an oral combination of decitabine and cedazuridine tablets with venetoclax for the treatment of newly diagnosed acute myeloid leukemia in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
                                                                                              indication source text
                                                                                              On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
                                                                                              opening context blocks
                                                                                              1. On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
                                                                                              tumor type mapping hints
                                                                                              1. leukemia
                                                                                              mapping status
                                                                                              heuristic_requires_editorial_review
                                                                                              regulatory meaning
                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                              source url
                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute
                                                                                              evidence source url
                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute
                                                                                              source basis
                                                                                              individual FDA notification page
                                                                                              source locator
                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                              index date
                                                                                              2026-05-13
                                                                                              index description
                                                                                              On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
                                                                                              provenance
                                                                                              retrieved at
                                                                                              2026-09-09T23:21:34.834664+00:00
                                                                                              local html
                                                                                              pages/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute.html
                                                                                              sha256
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                                                                                              headers file
                                                                                              pages/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute.headers.txt
                                                                                              full text file
                                                                                              pages/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute.txt
                                                                                              linked prescribing information
                                                                                                nct ids
                                                                                                1. NCT04657081
                                                                                                quality flags
                                                                                                  verification status
                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                  2026-05-08 · FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma
                                                                                                  id
                                                                                                  fda-da34fd1212e64f9b
                                                                                                  event type
                                                                                                  fda_oncology_approval_notification
                                                                                                  event date
                                                                                                  2026-05-08
                                                                                                  title
                                                                                                  FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma
                                                                                                  drug or regimen
                                                                                                  zenocutuzumab-zbco
                                                                                                  approval date
                                                                                                  2026-05-08
                                                                                                  approval type
                                                                                                  Source null
                                                                                                  approval type evidence
                                                                                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                  indication summary
                                                                                                  FDA approved zenocutuzumab-zbco for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy.
                                                                                                  indication source text
                                                                                                  On May 8, 2026, the Food and Drug Administration approved zenocutuzumab-zbco (Bizengri, Partner Therapeutics, Inc.) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy.
                                                                                                  opening context blocks
                                                                                                  1. On May 8, 2026, the Food and Drug Administration approved zenocutuzumab-zbco (Bizengri, Partner Therapeutics, Inc.) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy.
                                                                                                  2. This application is part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program, which is designed to accelerate the review of products with the potential to address key national priorities.
                                                                                                  tumor type mapping hints
                                                                                                  1. biliary
                                                                                                  mapping status
                                                                                                  heuristic_requires_editorial_review
                                                                                                  regulatory meaning
                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                  source url
                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zenocutuzumab-zbco-advanced-unresectable-or-metastatic-cholangiocarcinoma
                                                                                                  evidence source url
                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zenocutuzumab-zbco-advanced-unresectable-or-metastatic-cholangiocarcinoma
                                                                                                  source basis
                                                                                                  individual FDA notification page
                                                                                                  source locator
                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                  index date
                                                                                                  2026-05-08
                                                                                                  index description
                                                                                                  On May 8, 2026, the Food and Drug Administration approved zenocutuzumab-zbco (Bizengri, Partner Therapeutics, Inc.) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy.
                                                                                                  provenance
                                                                                                  retrieved at
                                                                                                  2026-09-09T23:21:36.892308+00:00
                                                                                                  local html
                                                                                                  pages/fda-approves-zenocutuzumab-zbco-advanced-unresectable-or-metastatic-cholangiocarcinoma.html
                                                                                                  sha256
                                                                                                  e05a6a6a8f765c123b07cf3eb7306ee76bf73e8935411f6f325ddc8eb571d906
                                                                                                  headers file
                                                                                                  pages/fda-approves-zenocutuzumab-zbco-advanced-unresectable-or-metastatic-cholangiocarcinoma.headers.txt
                                                                                                  full text file
                                                                                                  pages/fda-approves-zenocutuzumab-zbco-advanced-unresectable-or-metastatic-cholangiocarcinoma.txt
                                                                                                  linked prescribing information
                                                                                                    nct ids
                                                                                                    1. NCT02912949
                                                                                                    quality flags
                                                                                                      verification status
                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                      2026-05-01 · FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
                                                                                                      id
                                                                                                      fda-139bc569cd69b40c
                                                                                                      event type
                                                                                                      fda_oncology_approval_notification
                                                                                                      event date
                                                                                                      2026-05-01
                                                                                                      title
                                                                                                      FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
                                                                                                      drug or regimen
                                                                                                      vepdegestrant
                                                                                                      approval date
                                                                                                      2026-05-01
                                                                                                      approval type
                                                                                                      Source null
                                                                                                      approval type evidence
                                                                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                      indication summary
                                                                                                      FDA approved vepdegestrant, a heterobifunctional protein degrader, for adults with estrogen receptor -positive, human epidermal growth factor receptor 2 -negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
                                                                                                      indication source text
                                                                                                      On May 1, 2026, the Food and Drug Administration approved vepdegestrant (Veppanu, Arvinas Operations, Inc.), a heterobifunctional protein degrader, for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
                                                                                                      opening context blocks
                                                                                                      1. On May 1, 2026, the Food and Drug Administration approved vepdegestrant (Veppanu, Arvinas Operations, Inc.), a heterobifunctional protein degrader, for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
                                                                                                      2. FDA also approved the Guardant360 CDx as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with vepdegestrant.
                                                                                                      tumor type mapping hints
                                                                                                      1. breast
                                                                                                      mapping status
                                                                                                      heuristic_requires_editorial_review
                                                                                                      regulatory meaning
                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                      source url
                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast
                                                                                                      evidence source url
                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast
                                                                                                      source basis
                                                                                                      individual FDA notification page
                                                                                                      source locator
                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                      index date
                                                                                                      2026-05-01
                                                                                                      index description
                                                                                                      On May 1, 2026, the Food and Drug Administration approved vepdegestrant (Veppanu, Arvinas Operations, Inc.), a heterobifunctional protein degrader, for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
                                                                                                      provenance
                                                                                                      retrieved at
                                                                                                      2026-09-09T23:21:37.788973+00:00
                                                                                                      local html
                                                                                                      pages/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast.html
                                                                                                      sha256
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                                                                                                      headers file
                                                                                                      pages/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast.headers.txt
                                                                                                      full text file
                                                                                                      pages/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast.txt
                                                                                                      linked prescribing information
                                                                                                        nct ids
                                                                                                        1. NCT05654623
                                                                                                        quality flags
                                                                                                          verification status
                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                          2026-03-25 · FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
                                                                                                          id
                                                                                                          fda-d4ea94bc27b96b36
                                                                                                          event type
                                                                                                          fda_oncology_approval_notification
                                                                                                          event date
                                                                                                          2026-03-25
                                                                                                          title
                                                                                                          FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
                                                                                                          drug or regimen
                                                                                                          relacorilant with nab-paclitaxel
                                                                                                          approval date
                                                                                                          2026-03-25
                                                                                                          approval type
                                                                                                          Source null
                                                                                                          approval type evidence
                                                                                                          FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                          indication summary
                                                                                                          FDA approved relacorilant, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
                                                                                                          indication source text
                                                                                                          On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
                                                                                                          opening context blocks
                                                                                                          1. On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
                                                                                                          tumor type mapping hints
                                                                                                          1. ovarian
                                                                                                          mapping status
                                                                                                          heuristic_requires_editorial_review
                                                                                                          regulatory meaning
                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                          source url
                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
                                                                                                          evidence source url
                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
                                                                                                          source basis
                                                                                                          individual FDA notification page
                                                                                                          source locator
                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                          index date
                                                                                                          2026-03-25
                                                                                                          index description
                                                                                                          On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
                                                                                                          provenance
                                                                                                          retrieved at
                                                                                                          2026-09-09T23:21:38.939918+00:00
                                                                                                          local html
                                                                                                          pages/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or.html
                                                                                                          sha256
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                                                                                                          headers file
                                                                                                          pages/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or.headers.txt
                                                                                                          full text file
                                                                                                          pages/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or.txt
                                                                                                          linked prescribing information
                                                                                                            nct ids
                                                                                                            1. NCT05257408
                                                                                                            quality flags
                                                                                                              verification status
                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                              2026-03-20 · FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma
                                                                                                              id
                                                                                                              fda-491ef4b41b9bb54f
                                                                                                              event type
                                                                                                              fda_oncology_approval_notification
                                                                                                              event date
                                                                                                              2026-03-20
                                                                                                              title
                                                                                                              FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma
                                                                                                              drug or regimen
                                                                                                              nivolumab with chemotherapy
                                                                                                              approval date
                                                                                                              2026-03-20
                                                                                                              approval type
                                                                                                              Source null
                                                                                                              approval type evidence
                                                                                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                              indication summary
                                                                                                              FDA approved nivolumab with doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma . The FDA also granted traditional approval to nivolumab for the following indications in adults with relapsed or refractory cHL:
                                                                                                              indication source text
                                                                                                              On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). The FDA also granted traditional approval to nivolumab for the following indications in adults with relapsed or refractory cHL:
                                                                                                              opening context blocks
                                                                                                              1. On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). The FDA also granted traditional approval to nivolumab for the following indications in adults with relapsed or refractory cHL:
                                                                                                              2. after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
                                                                                                              3. after three or more lines of systemic therapy that includes autologous HSCT.
                                                                                                              4. Nivolumab received accelerated approval for these indications in 2016 and 2017, respectively.
                                                                                                              tumor type mapping hints
                                                                                                              1. lymphoma
                                                                                                              mapping status
                                                                                                              heuristic_requires_editorial_review
                                                                                                              regulatory meaning
                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                              source url
                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma
                                                                                                              evidence source url
                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma
                                                                                                              source basis
                                                                                                              individual FDA notification page
                                                                                                              source locator
                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                              index date
                                                                                                              2026-03-20
                                                                                                              index description
                                                                                                              On March 20, 2026, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).
                                                                                                              provenance
                                                                                                              retrieved at
                                                                                                              2026-09-09T23:21:40.076792+00:00
                                                                                                              local html
                                                                                                              pages/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma.html
                                                                                                              sha256
                                                                                                              9ac6a6b28118a1702811db77510dac5e9fd62b8c44f56c18075dc019120a4da0
                                                                                                              headers file
                                                                                                              pages/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma.headers.txt
                                                                                                              full text file
                                                                                                              pages/fda-approves-nivolumab-chemotherapy-previously-untreated-hodgkin-lymphoma.txt
                                                                                                              linked prescribing information
                                                                                                                nct ids
                                                                                                                1. NCT03907488
                                                                                                                quality flags
                                                                                                                1. possible_multiple_indications_review
                                                                                                                2. multiple_regulatory_actions_require_indication_split
                                                                                                                verification status
                                                                                                                source_extracted_not_clinically_reviewed
                                                                                                                2026-03-05 · FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
                                                                                                                id
                                                                                                                fda-b050e96dd06339f0
                                                                                                                event type
                                                                                                                fda_oncology_approval_notification
                                                                                                                event date
                                                                                                                2026-03-05
                                                                                                                title
                                                                                                                FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
                                                                                                                drug or regimen
                                                                                                                teclistamab in combination with daratumumab hyaluronidase-fihj
                                                                                                                approval date
                                                                                                                2026-03-05
                                                                                                                approval type
                                                                                                                Source null
                                                                                                                approval type evidence
                                                                                                                FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                indication summary
                                                                                                                FDA approved teclistamab in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
                                                                                                                indication source text
                                                                                                                On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
                                                                                                                opening context blocks
                                                                                                                1. On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
                                                                                                                2. Today’s approval also converts the accelerated approval to traditional approval for teclistamab, as monotherapy, in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Teclistamab received accelerated approval for this indication in 2022.
                                                                                                                3. This application is part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program, which is designed to accelerate the review of products with the potential to address key national priorities.
                                                                                                                tumor type mapping hints
                                                                                                                1. myeloma
                                                                                                                mapping status
                                                                                                                heuristic_requires_editorial_review
                                                                                                                regulatory meaning
                                                                                                                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                source url
                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-combination-daratumumab-hyaluronidase-fihj-relapsed-or-refractory-multiple
                                                                                                                evidence source url
                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-combination-daratumumab-hyaluronidase-fihj-relapsed-or-refractory-multiple
                                                                                                                source basis
                                                                                                                individual FDA notification page
                                                                                                                source locator
                                                                                                                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                index date
                                                                                                                2026-03-05
                                                                                                                index description
                                                                                                                On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
                                                                                                                provenance
                                                                                                                retrieved at
                                                                                                                2026-09-09T23:21:40.802333+00:00
                                                                                                                local html
                                                                                                                pages/fda-approves-teclistamab-combination-daratumumab-hyaluronidase-fihj-relapsed-or-refractory-multiple.html
                                                                                                                sha256
                                                                                                                d2892faec2cf65462c6a53317ed176a7316dffe3efb6efeb108bc46cd5e6bd04
                                                                                                                headers file
                                                                                                                pages/fda-approves-teclistamab-combination-daratumumab-hyaluronidase-fihj-relapsed-or-refractory-multiple.headers.txt
                                                                                                                full text file
                                                                                                                pages/fda-approves-teclistamab-combination-daratumumab-hyaluronidase-fihj-relapsed-or-refractory-multiple.txt
                                                                                                                linked prescribing information
                                                                                                                  nct ids
                                                                                                                  1. NCT05083169
                                                                                                                  quality flags
                                                                                                                    verification status
                                                                                                                    source_extracted_not_clinically_reviewed
                                                                                                                    2026-02-26 · FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
                                                                                                                    id
                                                                                                                    fda-3a7f03155778019c
                                                                                                                    event type
                                                                                                                    fda_oncology_approval_notification
                                                                                                                    event date
                                                                                                                    2026-02-26
                                                                                                                    title
                                                                                                                    FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer
                                                                                                                    drug or regimen
                                                                                                                    zongertinib
                                                                                                                    approval date
                                                                                                                    2026-02-26
                                                                                                                    approval type
                                                                                                                    accelerated
                                                                                                                    approval type evidence
                                                                                                                    accelerated explicitly stated in title/opening
                                                                                                                    indication summary
                                                                                                                    FDA approved zongertinib, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
                                                                                                                    indication source text
                                                                                                                    On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
                                                                                                                    opening context blocks
                                                                                                                    1. On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
                                                                                                                    2. This application is part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program, which is designed to accelerate the review of products with the potential to address key national priorities.
                                                                                                                    tumor type mapping hints
                                                                                                                    1. lung
                                                                                                                    mapping status
                                                                                                                    heuristic_requires_editorial_review
                                                                                                                    regulatory meaning
                                                                                                                    Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                    source url
                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell
                                                                                                                    evidence source url
                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell
                                                                                                                    source basis
                                                                                                                    individual FDA notification page
                                                                                                                    source locator
                                                                                                                    Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                    index date
                                                                                                                    2026-02-26
                                                                                                                    index description
                                                                                                                    On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
                                                                                                                    provenance
                                                                                                                    retrieved at
                                                                                                                    2026-09-09T23:21:41.989432+00:00
                                                                                                                    local html
                                                                                                                    pages/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell.html
                                                                                                                    sha256
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                                                                                                                    headers file
                                                                                                                    pages/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell.headers.txt
                                                                                                                    full text file
                                                                                                                    pages/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell.txt
                                                                                                                    linked prescribing information
                                                                                                                      nct ids
                                                                                                                      1. NCT04886804
                                                                                                                      quality flags
                                                                                                                        verification status
                                                                                                                        source_extracted_not_clinically_reviewed
                                                                                                                        2026-02-24 · FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation
                                                                                                                        id
                                                                                                                        fda-d5666ec96b2af4ed
                                                                                                                        event type
                                                                                                                        fda_oncology_approval_notification
                                                                                                                        event date
                                                                                                                        2026-02-24
                                                                                                                        title
                                                                                                                        FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation
                                                                                                                        drug or regimen
                                                                                                                        encorafenib
                                                                                                                        approval date
                                                                                                                        2026-02-24
                                                                                                                        approval type
                                                                                                                        traditional
                                                                                                                        approval type evidence
                                                                                                                        traditional explicitly stated in title/opening
                                                                                                                        indication summary
                                                                                                                        FDA approved encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024.
                                                                                                                        indication source text
                                                                                                                        On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024.
                                                                                                                        opening context blocks
                                                                                                                        1. On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024.
                                                                                                                        tumor type mapping hints
                                                                                                                        1. colorectal
                                                                                                                        mapping status
                                                                                                                        heuristic_requires_editorial_review
                                                                                                                        regulatory meaning
                                                                                                                        Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                        source url
                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-encorafenib-metastatic-colorectal-cancer-braf-v600e-mutation
                                                                                                                        evidence source url
                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-encorafenib-metastatic-colorectal-cancer-braf-v600e-mutation
                                                                                                                        source basis
                                                                                                                        individual FDA notification page
                                                                                                                        source locator
                                                                                                                        Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                        index date
                                                                                                                        2026-02-24
                                                                                                                        index description
                                                                                                                        On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024.
                                                                                                                        provenance
                                                                                                                        retrieved at
                                                                                                                        2026-09-09T23:21:42.890046+00:00
                                                                                                                        local html
                                                                                                                        pages/fda-grants-traditional-approval-encorafenib-metastatic-colorectal-cancer-braf-v600e-mutation.html
                                                                                                                        sha256
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                                                                                                                        headers file
                                                                                                                        pages/fda-grants-traditional-approval-encorafenib-metastatic-colorectal-cancer-braf-v600e-mutation.headers.txt
                                                                                                                        full text file
                                                                                                                        pages/fda-grants-traditional-approval-encorafenib-metastatic-colorectal-cancer-braf-v600e-mutation.txt
                                                                                                                        linked prescribing information
                                                                                                                          nct ids
                                                                                                                          1. NCT04607421
                                                                                                                          quality flags
                                                                                                                            verification status
                                                                                                                            source_extracted_not_clinically_reviewed
                                                                                                                            2026-02-19 · FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukemia or small lymphocytic lymphoma
                                                                                                                            id
                                                                                                                            fda-2484637c7ad88112
                                                                                                                            event type
                                                                                                                            fda_oncology_approval_notification
                                                                                                                            event date
                                                                                                                            2026-02-19
                                                                                                                            title
                                                                                                                            FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukemia or small lymphocytic lymphoma
                                                                                                                            drug or regimen
                                                                                                                            acalabrutinib with venetoclax
                                                                                                                            approval date
                                                                                                                            2026-02-19
                                                                                                                            approval type
                                                                                                                            Source null
                                                                                                                            approval type evidence
                                                                                                                            FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                            indication summary
                                                                                                                            FDA approved acalabrutinib tablets and capsules in combination with venetoclax for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma .
                                                                                                                            indication source text
                                                                                                                            On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
                                                                                                                            opening context blocks
                                                                                                                            1. On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
                                                                                                                            tumor type mapping hints
                                                                                                                            1. lymphoma
                                                                                                                            2. leukemia
                                                                                                                            mapping status
                                                                                                                            heuristic_requires_editorial_review
                                                                                                                            regulatory meaning
                                                                                                                            Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                            source url
                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma
                                                                                                                            evidence source url
                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma
                                                                                                                            source basis
                                                                                                                            individual FDA notification page
                                                                                                                            source locator
                                                                                                                            Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                            index date
                                                                                                                            2026-02-19
                                                                                                                            index description
                                                                                                                            On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
                                                                                                                            provenance
                                                                                                                            retrieved at
                                                                                                                            2026-09-09T23:21:43.917665+00:00
                                                                                                                            local html
                                                                                                                            pages/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma.html
                                                                                                                            sha256
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                                                                                                                            headers file
                                                                                                                            pages/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma.headers.txt
                                                                                                                            full text file
                                                                                                                            pages/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma.txt
                                                                                                                            linked prescribing information
                                                                                                                              nct ids
                                                                                                                              1. NCT03836261
                                                                                                                              quality flags
                                                                                                                                verification status
                                                                                                                                source_extracted_not_clinically_reviewed
                                                                                                                                2026-02-10 · FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
                                                                                                                                id
                                                                                                                                fda-de7303eac1be47e8
                                                                                                                                event type
                                                                                                                                fda_oncology_approval_notification
                                                                                                                                event date
                                                                                                                                2026-02-10
                                                                                                                                title
                                                                                                                                FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
                                                                                                                                drug or regimen
                                                                                                                                pembrolizumab with paclitaxel
                                                                                                                                approval date
                                                                                                                                2026-02-10
                                                                                                                                approval type
                                                                                                                                Source null
                                                                                                                                approval type evidence
                                                                                                                                FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                indication summary
                                                                                                                                FDA approved pembrolizumab as well as pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
                                                                                                                                indication source text
                                                                                                                                On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
                                                                                                                                opening context blocks
                                                                                                                                1. On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
                                                                                                                                2. FDA also approved the PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Inc) as a companion diagnostic device to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) for treatment with pembrolizumab.
                                                                                                                                tumor type mapping hints
                                                                                                                                1. ovarian
                                                                                                                                mapping status
                                                                                                                                heuristic_requires_editorial_review
                                                                                                                                regulatory meaning
                                                                                                                                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                source url
                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
                                                                                                                                evidence source url
                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
                                                                                                                                source basis
                                                                                                                                individual FDA notification page
                                                                                                                                source locator
                                                                                                                                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                index date
                                                                                                                                2026-02-10
                                                                                                                                index description
                                                                                                                                On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
                                                                                                                                provenance
                                                                                                                                retrieved at
                                                                                                                                2026-09-09T23:21:44.899113+00:00
                                                                                                                                local html
                                                                                                                                pages/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or.html
                                                                                                                                sha256
                                                                                                                                cd9a57b9e0182e2a78aecb399954b4fe462cf668844cd36051fb95288a547cee
                                                                                                                                headers file
                                                                                                                                pages/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or.headers.txt
                                                                                                                                full text file
                                                                                                                                pages/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or.txt
                                                                                                                                linked prescribing information
                                                                                                                                  nct ids
                                                                                                                                  1. NCT05116189
                                                                                                                                  quality flags
                                                                                                                                    verification status
                                                                                                                                    source_extracted_not_clinically_reviewed
                                                                                                                                    2026-01-27 · FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
                                                                                                                                    id
                                                                                                                                    fda-af9011a2d75e5c91
                                                                                                                                    event type
                                                                                                                                    fda_oncology_approval_notification
                                                                                                                                    event date
                                                                                                                                    2026-01-27
                                                                                                                                    title
                                                                                                                                    FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
                                                                                                                                    drug or regimen
                                                                                                                                    daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone
                                                                                                                                    approval date
                                                                                                                                    2026-01-27
                                                                                                                                    approval type
                                                                                                                                    Source null
                                                                                                                                    approval type evidence
                                                                                                                                    FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                    indication summary
                                                                                                                                    FDA approved daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant .
                                                                                                                                    indication source text
                                                                                                                                    On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
                                                                                                                                    opening context blocks
                                                                                                                                    1. On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
                                                                                                                                    tumor type mapping hints
                                                                                                                                    1. myeloma
                                                                                                                                    mapping status
                                                                                                                                    heuristic_requires_editorial_review
                                                                                                                                    regulatory meaning
                                                                                                                                    Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                    source url
                                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly
                                                                                                                                    evidence source url
                                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly
                                                                                                                                    source basis
                                                                                                                                    individual FDA notification page
                                                                                                                                    source locator
                                                                                                                                    Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                    index date
                                                                                                                                    2026-01-27
                                                                                                                                    index description
                                                                                                                                    On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
                                                                                                                                    provenance
                                                                                                                                    retrieved at
                                                                                                                                    2026-09-09T23:21:46.918459+00:00
                                                                                                                                    local html
                                                                                                                                    pages/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly.html
                                                                                                                                    sha256
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                                                                                                                                    headers file
                                                                                                                                    pages/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly.headers.txt
                                                                                                                                    full text file
                                                                                                                                    pages/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly.txt
                                                                                                                                    linked prescribing information
                                                                                                                                      nct ids
                                                                                                                                      1. NCT03652064
                                                                                                                                      quality flags
                                                                                                                                        verification status
                                                                                                                                        source_extracted_not_clinically_reviewed
                                                                                                                                        2025-12-17 · FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
                                                                                                                                        id
                                                                                                                                        fda-85818647aa43a4e8
                                                                                                                                        event type
                                                                                                                                        fda_oncology_approval_notification
                                                                                                                                        event date
                                                                                                                                        2025-12-17
                                                                                                                                        title
                                                                                                                                        FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
                                                                                                                                        drug or regimen
                                                                                                                                        amivantamab and hyaluronidase-lpuj
                                                                                                                                        approval date
                                                                                                                                        2025-12-17
                                                                                                                                        approval type
                                                                                                                                        Source null
                                                                                                                                        approval type evidence
                                                                                                                                        FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                        indication summary
                                                                                                                                        FDA approved amivantamab and hyaluronidase-lpuj for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab . See the prescribing information for the specific indications.
                                                                                                                                        indication source text
                                                                                                                                        On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.). See the prescribing information for the specific indications.
                                                                                                                                        opening context blocks
                                                                                                                                        1. On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.). See the prescribing information for the specific indications.
                                                                                                                                        tumor type mapping hints
                                                                                                                                          mapping status
                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                          regulatory meaning
                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                          source url
                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection
                                                                                                                                          evidence source url
                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection
                                                                                                                                          source basis
                                                                                                                                          individual FDA notification page
                                                                                                                                          source locator
                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                          index date
                                                                                                                                          2025-12-17
                                                                                                                                          index description
                                                                                                                                          On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.). See the prescribing information for the specific indications.
                                                                                                                                          provenance
                                                                                                                                          retrieved at
                                                                                                                                          2026-09-09T23:21:47.832997+00:00
                                                                                                                                          local html
                                                                                                                                          pages/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection.html
                                                                                                                                          sha256
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                                                                                                                                          headers file
                                                                                                                                          pages/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection.headers.txt
                                                                                                                                          full text file
                                                                                                                                          pages/fda-approves-amivantamab-and-hyaluronidase-lpuj-subcutaneous-injection.txt
                                                                                                                                          linked prescribing information
                                                                                                                                            nct ids
                                                                                                                                              quality flags
                                                                                                                                              1. tumor_mapping_unresolved
                                                                                                                                              2. possible_multiple_indications_review
                                                                                                                                              verification status
                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                              2025-12-17 · FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
                                                                                                                                              id
                                                                                                                                              fda-2f7bc8b820239b15
                                                                                                                                              event type
                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                              event date
                                                                                                                                              2025-12-17
                                                                                                                                              title
                                                                                                                                              FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
                                                                                                                                              drug or regimen
                                                                                                                                              rucaparib
                                                                                                                                              approval date
                                                                                                                                              2025-12-17
                                                                                                                                              approval type
                                                                                                                                              regular
                                                                                                                                              approval type evidence
                                                                                                                                              regular explicitly stated in title/opening
                                                                                                                                              indication summary
                                                                                                                                              FDA approved rucaparib for adults with a deleterious BRCA mutation -associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic . Rucaparib was granted accelerated approval in 2020 for a similar indication.
                                                                                                                                              indication source text
                                                                                                                                              On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx). Rucaparib was granted accelerated approval in 2020 for a similar indication.
                                                                                                                                              opening context blocks
                                                                                                                                              1. On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx). Rucaparib was granted accelerated approval in 2020 for a similar indication.
                                                                                                                                              tumor type mapping hints
                                                                                                                                              1. prostate
                                                                                                                                              mapping status
                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                              regulatory meaning
                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                              source url
                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer
                                                                                                                                              evidence source url
                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer
                                                                                                                                              source basis
                                                                                                                                              individual FDA notification page
                                                                                                                                              source locator
                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                              index date
                                                                                                                                              2025-12-17
                                                                                                                                              index description
                                                                                                                                              On December 17, 2025, the Food and Drug Administration approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx).
                                                                                                                                              provenance
                                                                                                                                              retrieved at
                                                                                                                                              2026-09-09T23:21:48.915171+00:00
                                                                                                                                              local html
                                                                                                                                              pages/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer.html
                                                                                                                                              sha256
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                                                                                                                                              headers file
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                                                                                                                                              full text file
                                                                                                                                              pages/fda-grants-regular-approval-rucaparib-metastatic-castration-resistant-prostate-cancer.txt
                                                                                                                                              linked prescribing information
                                                                                                                                                nct ids
                                                                                                                                                1. NCT02975934
                                                                                                                                                quality flags
                                                                                                                                                  verification status
                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                  2025-12-15 · FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer
                                                                                                                                                  id
                                                                                                                                                  fda-838a85e7ab9c5846
                                                                                                                                                  event type
                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                  event date
                                                                                                                                                  2025-12-15
                                                                                                                                                  title
                                                                                                                                                  FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer
                                                                                                                                                  drug or regimen
                                                                                                                                                  fam-trastuzumab deruxtecan-nxki with pertuzumab
                                                                                                                                                  approval date
                                                                                                                                                  2025-12-15
                                                                                                                                                  approval type
                                                                                                                                                  Source null
                                                                                                                                                  approval type evidence
                                                                                                                                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                  indication summary
                                                                                                                                                  FDA approved fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer as determined by an FDA-approved test.
                                                                                                                                                  indication source text
                                                                                                                                                  On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.
                                                                                                                                                  opening context blocks
                                                                                                                                                  1. On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.
                                                                                                                                                  2. FDA also approved the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and HER2 Dual ISH DNA Probe Cocktail as companion diagnostic devices for selecting HER2-positive (HER2 IHC3+ or ISH+) breast cancer patients for treatment with fam-trastuzumab deruxtecan-nxki in combination with pertuzumab.
                                                                                                                                                  tumor type mapping hints
                                                                                                                                                  1. breast
                                                                                                                                                  mapping status
                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                  regulatory meaning
                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                  source url
                                                                                                                                                  https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive
                                                                                                                                                  evidence source url
                                                                                                                                                  https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive
                                                                                                                                                  source basis
                                                                                                                                                  individual FDA notification page
                                                                                                                                                  source locator
                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                  index date
                                                                                                                                                  2025-12-15
                                                                                                                                                  index description
                                                                                                                                                  On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.
                                                                                                                                                  provenance
                                                                                                                                                  retrieved at
                                                                                                                                                  2026-09-09T23:21:49.906335+00:00
                                                                                                                                                  local html
                                                                                                                                                  pages/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive.html
                                                                                                                                                  sha256
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                                                                                                                                                  pages/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive.headers.txt
                                                                                                                                                  full text file
                                                                                                                                                  pages/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive.txt
                                                                                                                                                  linked prescribing information
                                                                                                                                                    nct ids
                                                                                                                                                    1. NCT04784715
                                                                                                                                                    quality flags
                                                                                                                                                      verification status
                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                      2025-12-12 · FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
                                                                                                                                                      id
                                                                                                                                                      fda-3afb067b5b05cacc
                                                                                                                                                      event type
                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                      event date
                                                                                                                                                      2025-12-12
                                                                                                                                                      title
                                                                                                                                                      FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
                                                                                                                                                      drug or regimen
                                                                                                                                                      niraparib and abiraterone acetate plus prednisone
                                                                                                                                                      approval date
                                                                                                                                                      2025-12-12
                                                                                                                                                      approval type
                                                                                                                                                      Source null
                                                                                                                                                      approval type evidence
                                                                                                                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                      indication summary
                                                                                                                                                      FDA approved niraparib and abiraterone acetate with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.
                                                                                                                                                      indication source text
                                                                                                                                                      On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.
                                                                                                                                                      opening context blocks
                                                                                                                                                      1. On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.
                                                                                                                                                      tumor type mapping hints
                                                                                                                                                      1. prostate
                                                                                                                                                      mapping status
                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                      regulatory meaning
                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                      source url
                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration
                                                                                                                                                      evidence source url
                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration
                                                                                                                                                      source basis
                                                                                                                                                      individual FDA notification page
                                                                                                                                                      source locator
                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                      index date
                                                                                                                                                      2025-12-12
                                                                                                                                                      index description
                                                                                                                                                      On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.
                                                                                                                                                      provenance
                                                                                                                                                      retrieved at
                                                                                                                                                      2026-09-09T23:21:50.929636+00:00
                                                                                                                                                      local html
                                                                                                                                                      pages/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration.html
                                                                                                                                                      sha256
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                                                                                                                                                      full text file
                                                                                                                                                      pages/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration.txt
                                                                                                                                                      linked prescribing information
                                                                                                                                                        nct ids
                                                                                                                                                        1. NCT04497844
                                                                                                                                                        quality flags
                                                                                                                                                          verification status
                                                                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                                                                          2025-12-04 · FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma
                                                                                                                                                          id
                                                                                                                                                          fda-9123ee1df52ccb91
                                                                                                                                                          event type
                                                                                                                                                          fda_oncology_approval_notification
                                                                                                                                                          event date
                                                                                                                                                          2025-12-04
                                                                                                                                                          title
                                                                                                                                                          FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma
                                                                                                                                                          drug or regimen
                                                                                                                                                          lisocabtagene maraleucel
                                                                                                                                                          approval date
                                                                                                                                                          2025-12-04
                                                                                                                                                          approval type
                                                                                                                                                          Source null
                                                                                                                                                          approval type evidence
                                                                                                                                                          FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                          indication summary
                                                                                                                                                          FDA approved lisocabtagene maraleucel for adults with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy.
                                                                                                                                                          indication source text
                                                                                                                                                          On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.
                                                                                                                                                          opening context blocks
                                                                                                                                                          1. On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.
                                                                                                                                                          tumor type mapping hints
                                                                                                                                                          1. lymphoma
                                                                                                                                                          mapping status
                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                          regulatory meaning
                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                          source url
                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
                                                                                                                                                          evidence source url
                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
                                                                                                                                                          source basis
                                                                                                                                                          individual FDA notification page
                                                                                                                                                          source locator
                                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                          index date
                                                                                                                                                          2025-12-04
                                                                                                                                                          index description
                                                                                                                                                          On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy
                                                                                                                                                          provenance
                                                                                                                                                          retrieved at
                                                                                                                                                          2026-09-09T23:21:51.957154+00:00
                                                                                                                                                          local html
                                                                                                                                                          pages/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma.html
                                                                                                                                                          sha256
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                                                                                                                                                          headers file
                                                                                                                                                          pages/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma.headers.txt
                                                                                                                                                          full text file
                                                                                                                                                          pages/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma.txt
                                                                                                                                                          linked prescribing information
                                                                                                                                                            nct ids
                                                                                                                                                            1. NCT04245839
                                                                                                                                                            quality flags
                                                                                                                                                              verification status
                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                              2025-12-03 · FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma
                                                                                                                                                              id
                                                                                                                                                              fda-a90b83cba53cf44c
                                                                                                                                                              event type
                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                              event date
                                                                                                                                                              2025-12-03
                                                                                                                                                              title
                                                                                                                                                              FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma
                                                                                                                                                              drug or regimen
                                                                                                                                                              pirtobrutinib
                                                                                                                                                              approval date
                                                                                                                                                              2025-12-03
                                                                                                                                                              approval type
                                                                                                                                                              traditional
                                                                                                                                                              approval type evidence
                                                                                                                                                              traditional explicitly stated in title/opening
                                                                                                                                                              indication summary
                                                                                                                                                              FDA approved pirtobrutinib for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
                                                                                                                                                              indication source text
                                                                                                                                                              On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
                                                                                                                                                              opening context blocks
                                                                                                                                                              1. On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
                                                                                                                                                              tumor type mapping hints
                                                                                                                                                              1. lymphoma
                                                                                                                                                              2. leukemia
                                                                                                                                                              mapping status
                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                              regulatory meaning
                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                              source url
                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic
                                                                                                                                                              evidence source url
                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic
                                                                                                                                                              source basis
                                                                                                                                                              individual FDA notification page
                                                                                                                                                              source locator
                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                              index date
                                                                                                                                                              2025-12-03
                                                                                                                                                              index description
                                                                                                                                                              On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
                                                                                                                                                              provenance
                                                                                                                                                              retrieved at
                                                                                                                                                              2026-09-09T23:21:53.032074+00:00
                                                                                                                                                              local html
                                                                                                                                                              pages/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic.html
                                                                                                                                                              sha256
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                                                                                                                                                              headers file
                                                                                                                                                              pages/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic.headers.txt
                                                                                                                                                              full text file
                                                                                                                                                              pages/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic.txt
                                                                                                                                                              linked prescribing information
                                                                                                                                                                nct ids
                                                                                                                                                                  quality flags
                                                                                                                                                                  1. multiple_regulatory_actions_require_indication_split
                                                                                                                                                                  verification status
                                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                                  2025-11-25 · FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma
                                                                                                                                                                  id
                                                                                                                                                                  fda-25cb7546eed078fb
                                                                                                                                                                  event type
                                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                                  event date
                                                                                                                                                                  2025-11-25
                                                                                                                                                                  title
                                                                                                                                                                  FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma
                                                                                                                                                                  drug or regimen
                                                                                                                                                                  durvalumab
                                                                                                                                                                  approval date
                                                                                                                                                                  2025-11-25
                                                                                                                                                                  approval type
                                                                                                                                                                  Source null
                                                                                                                                                                  approval type evidence
                                                                                                                                                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                  indication summary
                                                                                                                                                                  FDA approved durvalumab with fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma .
                                                                                                                                                                  indication source text
                                                                                                                                                                  On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
                                                                                                                                                                  opening context blocks
                                                                                                                                                                  1. On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
                                                                                                                                                                  tumor type mapping hints
                                                                                                                                                                  1. gastric
                                                                                                                                                                  mapping status
                                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                                  regulatory meaning
                                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                  source url
                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma
                                                                                                                                                                  evidence source url
                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma
                                                                                                                                                                  source basis
                                                                                                                                                                  individual FDA notification page
                                                                                                                                                                  source locator
                                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                  index date
                                                                                                                                                                  2025-11-25
                                                                                                                                                                  index description
                                                                                                                                                                  On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
                                                                                                                                                                  provenance
                                                                                                                                                                  retrieved at
                                                                                                                                                                  2026-09-09T23:21:54.248905+00:00
                                                                                                                                                                  local html
                                                                                                                                                                  pages/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma.html
                                                                                                                                                                  sha256
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                                                                                                                                                                  headers file
                                                                                                                                                                  pages/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma.headers.txt
                                                                                                                                                                  full text file
                                                                                                                                                                  pages/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma.txt
                                                                                                                                                                  linked prescribing information
                                                                                                                                                                    nct ids
                                                                                                                                                                    1. NCT04592913
                                                                                                                                                                    quality flags
                                                                                                                                                                      verification status
                                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                                      2025-11-21 · FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
                                                                                                                                                                      id
                                                                                                                                                                      fda-645462b4c10c2fb2
                                                                                                                                                                      event type
                                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                                      event date
                                                                                                                                                                      2025-11-21
                                                                                                                                                                      title
                                                                                                                                                                      FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
                                                                                                                                                                      drug or regimen
                                                                                                                                                                      pembrolizumab with enfortumab vedotin-ejfv
                                                                                                                                                                      approval date
                                                                                                                                                                      2025-11-21
                                                                                                                                                                      approval type
                                                                                                                                                                      Source null
                                                                                                                                                                      approval type evidence
                                                                                                                                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                      indication summary
                                                                                                                                                                      FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin.
                                                                                                                                                                      indication source text
                                                                                                                                                                      On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.
                                                                                                                                                                      opening context blocks
                                                                                                                                                                      1. On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.
                                                                                                                                                                      tumor type mapping hints
                                                                                                                                                                      1. bladder
                                                                                                                                                                      mapping status
                                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                                      regulatory meaning
                                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                      source url
                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer
                                                                                                                                                                      evidence source url
                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer
                                                                                                                                                                      source basis
                                                                                                                                                                      individual FDA notification page
                                                                                                                                                                      source locator
                                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                      index date
                                                                                                                                                                      2025-11-21
                                                                                                                                                                      index description
                                                                                                                                                                      On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.
                                                                                                                                                                      provenance
                                                                                                                                                                      retrieved at
                                                                                                                                                                      2026-09-09T23:21:55.746814+00:00
                                                                                                                                                                      local html
                                                                                                                                                                      pages/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer.html
                                                                                                                                                                      sha256
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                                                                                                                                                                      headers file
                                                                                                                                                                      pages/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer.headers.txt
                                                                                                                                                                      full text file
                                                                                                                                                                      pages/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer.txt
                                                                                                                                                                      linked prescribing information
                                                                                                                                                                        nct ids
                                                                                                                                                                        1. NCT03924895
                                                                                                                                                                        quality flags
                                                                                                                                                                          verification status
                                                                                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                                                                                          2025-11-19 · FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
                                                                                                                                                                          id
                                                                                                                                                                          fda-a0a0b26c2d3a3702
                                                                                                                                                                          event type
                                                                                                                                                                          fda_oncology_approval_notification
                                                                                                                                                                          event date
                                                                                                                                                                          2025-11-19
                                                                                                                                                                          title
                                                                                                                                                                          FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
                                                                                                                                                                          drug or regimen
                                                                                                                                                                          tarlatamab-dlle
                                                                                                                                                                          approval date
                                                                                                                                                                          2025-11-19
                                                                                                                                                                          approval type
                                                                                                                                                                          traditional
                                                                                                                                                                          approval type evidence
                                                                                                                                                                          traditional explicitly stated in title/opening
                                                                                                                                                                          indication summary
                                                                                                                                                                          FDA approved tarlatamab-dlle for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.
                                                                                                                                                                          indication source text
                                                                                                                                                                          On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.
                                                                                                                                                                          opening context blocks
                                                                                                                                                                          1. On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.
                                                                                                                                                                          tumor type mapping hints
                                                                                                                                                                          1. lung
                                                                                                                                                                          mapping status
                                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                                          regulatory meaning
                                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                          source url
                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer
                                                                                                                                                                          evidence source url
                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer
                                                                                                                                                                          source basis
                                                                                                                                                                          individual FDA notification page
                                                                                                                                                                          source locator
                                                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                          index date
                                                                                                                                                                          2025-11-19
                                                                                                                                                                          index description
                                                                                                                                                                          On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024.
                                                                                                                                                                          provenance
                                                                                                                                                                          retrieved at
                                                                                                                                                                          2026-09-09T23:21:56.345146+00:00
                                                                                                                                                                          local html
                                                                                                                                                                          pages/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer.html
                                                                                                                                                                          sha256
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                                                                                                                                                                          headers file
                                                                                                                                                                          pages/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer.headers.txt
                                                                                                                                                                          full text file
                                                                                                                                                                          pages/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer.txt
                                                                                                                                                                          linked prescribing information
                                                                                                                                                                            nct ids
                                                                                                                                                                            1. NCT05740566
                                                                                                                                                                            quality flags
                                                                                                                                                                              verification status
                                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                                              2025-11-19 · FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis
                                                                                                                                                                              id
                                                                                                                                                                              fda-4127658b41da6e41
                                                                                                                                                                              event type
                                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                                              event date
                                                                                                                                                                              2025-11-19
                                                                                                                                                                              title
                                                                                                                                                                              FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis
                                                                                                                                                                              drug or regimen
                                                                                                                                                                              daratumumab and hyaluronidase-fihj
                                                                                                                                                                              approval date
                                                                                                                                                                              2025-11-19
                                                                                                                                                                              approval type
                                                                                                                                                                              traditional
                                                                                                                                                                              approval type evidence
                                                                                                                                                                              traditional explicitly stated in title/opening
                                                                                                                                                                              indication summary
                                                                                                                                                                              FDA approved daratumumab and hyaluronidase-fihj with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis. FDA granted accelerated approval for this indication in 2021.
                                                                                                                                                                              indication source text
                                                                                                                                                                              On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.
                                                                                                                                                                              opening context blocks
                                                                                                                                                                              1. On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.
                                                                                                                                                                              tumor type mapping hints
                                                                                                                                                                              1. al-amyloidosis
                                                                                                                                                                              mapping status
                                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                                              regulatory meaning
                                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                              source url
                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain
                                                                                                                                                                              evidence source url
                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain
                                                                                                                                                                              source basis
                                                                                                                                                                              individual FDA notification page
                                                                                                                                                                              source locator
                                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                              index date
                                                                                                                                                                              2025-11-19
                                                                                                                                                                              index description
                                                                                                                                                                              On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.
                                                                                                                                                                              provenance
                                                                                                                                                                              retrieved at
                                                                                                                                                                              2026-09-09T23:21:58.401469+00:00
                                                                                                                                                                              local html
                                                                                                                                                                              pages/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain.html
                                                                                                                                                                              sha256
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                                                                                                                                                                              headers file
                                                                                                                                                                              pages/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain.headers.txt
                                                                                                                                                                              full text file
                                                                                                                                                                              pages/fda-grants-traditional-approval-daratumumab-and-hyaluronidase-fihj-newly-diagnosed-light-chain.txt
                                                                                                                                                                              linked prescribing information
                                                                                                                                                                                nct ids
                                                                                                                                                                                1. NCT03201965
                                                                                                                                                                                quality flags
                                                                                                                                                                                1. multiple_regulatory_actions_require_indication_split
                                                                                                                                                                                2. may_be_supportive_care_or_nonmalignant_condition
                                                                                                                                                                                verification status
                                                                                                                                                                                source_extracted_not_clinically_reviewed
                                                                                                                                                                                2025-11-19 · FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
                                                                                                                                                                                id
                                                                                                                                                                                fda-2db0099d79952b23
                                                                                                                                                                                event type
                                                                                                                                                                                fda_oncology_approval_notification
                                                                                                                                                                                event date
                                                                                                                                                                                2025-11-19
                                                                                                                                                                                title
                                                                                                                                                                                FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
                                                                                                                                                                                drug or regimen
                                                                                                                                                                                selumetinib
                                                                                                                                                                                approval date
                                                                                                                                                                                2025-11-19
                                                                                                                                                                                approval type
                                                                                                                                                                                Source null
                                                                                                                                                                                approval type evidence
                                                                                                                                                                                FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                indication summary
                                                                                                                                                                                FDA approved selumetinib for adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas . FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.
                                                                                                                                                                                indication source text
                                                                                                                                                                                On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.
                                                                                                                                                                                opening context blocks
                                                                                                                                                                                1. On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.
                                                                                                                                                                                tumor type mapping hints
                                                                                                                                                                                1. neurofibromatosis
                                                                                                                                                                                mapping status
                                                                                                                                                                                heuristic_requires_editorial_review
                                                                                                                                                                                regulatory meaning
                                                                                                                                                                                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                source url
                                                                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform
                                                                                                                                                                                evidence source url
                                                                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform
                                                                                                                                                                                source basis
                                                                                                                                                                                individual FDA notification page
                                                                                                                                                                                source locator
                                                                                                                                                                                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                index date
                                                                                                                                                                                2025-11-19
                                                                                                                                                                                index description
                                                                                                                                                                                On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.
                                                                                                                                                                                provenance
                                                                                                                                                                                retrieved at
                                                                                                                                                                                2026-09-09T23:21:59.766897+00:00
                                                                                                                                                                                local html
                                                                                                                                                                                pages/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform.html
                                                                                                                                                                                sha256
                                                                                                                                                                                6b88b315fb57fcf74bbfcc8d3b1fcde54db5f8117bc6b076c7833fda2192b6f6
                                                                                                                                                                                headers file
                                                                                                                                                                                pages/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform.headers.txt
                                                                                                                                                                                full text file
                                                                                                                                                                                pages/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform.txt
                                                                                                                                                                                linked prescribing information
                                                                                                                                                                                  nct ids
                                                                                                                                                                                  1. NCT04924608
                                                                                                                                                                                  quality flags
                                                                                                                                                                                  1. may_be_supportive_care_or_nonmalignant_condition
                                                                                                                                                                                  verification status
                                                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                                                  2025-11-19 · FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
                                                                                                                                                                                  id
                                                                                                                                                                                  fda-26f47f4afac6d968
                                                                                                                                                                                  event type
                                                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                                                  event date
                                                                                                                                                                                  2025-11-19
                                                                                                                                                                                  title
                                                                                                                                                                                  FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
                                                                                                                                                                                  drug or regimen
                                                                                                                                                                                  sevabertinib
                                                                                                                                                                                  approval date
                                                                                                                                                                                  2025-11-19
                                                                                                                                                                                  approval type
                                                                                                                                                                                  accelerated
                                                                                                                                                                                  approval type evidence
                                                                                                                                                                                  accelerated explicitly stated in title/opening
                                                                                                                                                                                  indication summary
                                                                                                                                                                                  FDA approved sevabertinib, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
                                                                                                                                                                                  indication source text
                                                                                                                                                                                  On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
                                                                                                                                                                                  opening context blocks
                                                                                                                                                                                  1. On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
                                                                                                                                                                                  2. FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detectingHER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with sevabertinib.
                                                                                                                                                                                  tumor type mapping hints
                                                                                                                                                                                  1. lung
                                                                                                                                                                                  mapping status
                                                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                                                  regulatory meaning
                                                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                  source url
                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer
                                                                                                                                                                                  evidence source url
                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer
                                                                                                                                                                                  source basis
                                                                                                                                                                                  individual FDA notification page
                                                                                                                                                                                  source locator
                                                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                  index date
                                                                                                                                                                                  2025-11-19
                                                                                                                                                                                  index description
                                                                                                                                                                                  On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
                                                                                                                                                                                  provenance
                                                                                                                                                                                  retrieved at
                                                                                                                                                                                  2026-09-09T23:21:57.345529+00:00
                                                                                                                                                                                  local html
                                                                                                                                                                                  pages/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer.html
                                                                                                                                                                                  sha256
                                                                                                                                                                                  5d8a96c0f213962725996cb21e4ee6263dbff1d3d7053fb4b278971b476680cb
                                                                                                                                                                                  headers file
                                                                                                                                                                                  pages/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer.headers.txt
                                                                                                                                                                                  full text file
                                                                                                                                                                                  pages/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer.txt
                                                                                                                                                                                  linked prescribing information
                                                                                                                                                                                    nct ids
                                                                                                                                                                                    1. NCT05099172
                                                                                                                                                                                    quality flags
                                                                                                                                                                                      verification status
                                                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                                                      2025-11-18 · FDA approves epcoritamab-bysp for follicular lymphoma indications
                                                                                                                                                                                      id
                                                                                                                                                                                      fda-7a8e3c1432349ced
                                                                                                                                                                                      event type
                                                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                                                      event date
                                                                                                                                                                                      2025-11-18
                                                                                                                                                                                      title
                                                                                                                                                                                      FDA approves epcoritamab-bysp for follicular lymphoma indications
                                                                                                                                                                                      drug or regimen
                                                                                                                                                                                      epcoritamab-bysp
                                                                                                                                                                                      approval date
                                                                                                                                                                                      2025-11-18
                                                                                                                                                                                      approval type
                                                                                                                                                                                      Source null
                                                                                                                                                                                      approval type evidence
                                                                                                                                                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                      indication summary
                                                                                                                                                                                      FDA approved epcoritamab-bysp with lenalidomide and rituximab for relapsed or refractory follicular lymphoma . The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy .
                                                                                                                                                                                      indication source text
                                                                                                                                                                                      On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024).
                                                                                                                                                                                      opening context blocks
                                                                                                                                                                                      1. On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024).
                                                                                                                                                                                      tumor type mapping hints
                                                                                                                                                                                      1. lymphoma
                                                                                                                                                                                      mapping status
                                                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                                                      regulatory meaning
                                                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                      source url
                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications
                                                                                                                                                                                      evidence source url
                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications
                                                                                                                                                                                      source basis
                                                                                                                                                                                      individual FDA notification page
                                                                                                                                                                                      source locator
                                                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                      index date
                                                                                                                                                                                      2025-11-18
                                                                                                                                                                                      index description
                                                                                                                                                                                      On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024).
                                                                                                                                                                                      provenance
                                                                                                                                                                                      retrieved at
                                                                                                                                                                                      2026-09-09T23:22:00.675324+00:00
                                                                                                                                                                                      local html
                                                                                                                                                                                      pages/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications.html
                                                                                                                                                                                      sha256
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                                                                                                                                                                                      headers file
                                                                                                                                                                                      pages/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications.headers.txt
                                                                                                                                                                                      full text file
                                                                                                                                                                                      pages/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications.txt
                                                                                                                                                                                      linked prescribing information
                                                                                                                                                                                        nct ids
                                                                                                                                                                                        1. NCT05409066
                                                                                                                                                                                        quality flags
                                                                                                                                                                                        1. multiple_regulatory_actions_require_indication_split
                                                                                                                                                                                        verification status
                                                                                                                                                                                        source_extracted_not_clinically_reviewed
                                                                                                                                                                                        2025-11-13 · FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation
                                                                                                                                                                                        id
                                                                                                                                                                                        fda-970653d3c34dd8d5
                                                                                                                                                                                        event type
                                                                                                                                                                                        fda_oncology_approval_notification
                                                                                                                                                                                        event date
                                                                                                                                                                                        2025-11-13
                                                                                                                                                                                        title
                                                                                                                                                                                        FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation
                                                                                                                                                                                        drug or regimen
                                                                                                                                                                                        ziftomenib
                                                                                                                                                                                        approval date
                                                                                                                                                                                        2025-11-13
                                                                                                                                                                                        approval type
                                                                                                                                                                                        Source null
                                                                                                                                                                                        approval type evidence
                                                                                                                                                                                        FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                        indication summary
                                                                                                                                                                                        FDA approved ziftomenib, a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options.
                                                                                                                                                                                        indication source text
                                                                                                                                                                                        On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
                                                                                                                                                                                        opening context blocks
                                                                                                                                                                                          tumor type mapping hints
                                                                                                                                                                                          1. leukemia
                                                                                                                                                                                          mapping status
                                                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                                                          regulatory meaning
                                                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                          source url
                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation
                                                                                                                                                                                          evidence source url
                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications
                                                                                                                                                                                          source basis
                                                                                                                                                                                          FDA index only; linked page returned a soft 404
                                                                                                                                                                                          source locator
                                                                                                                                                                                          Index row
                                                                                                                                                                                          index date
                                                                                                                                                                                          2025-11-13
                                                                                                                                                                                          index description
                                                                                                                                                                                          On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
                                                                                                                                                                                          provenance
                                                                                                                                                                                          retrieved at
                                                                                                                                                                                          2026-09-09T23:22:02.492041+00:00
                                                                                                                                                                                          local html
                                                                                                                                                                                          pages/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation.html
                                                                                                                                                                                          sha256
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                                                                                                                                                                                          headers file
                                                                                                                                                                                          pages/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation.headers.txt
                                                                                                                                                                                          full text file
                                                                                                                                                                                          pages/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation.txt
                                                                                                                                                                                          linked prescribing information
                                                                                                                                                                                            nct ids
                                                                                                                                                                                              quality flags
                                                                                                                                                                                              1. linked_page_soft_404
                                                                                                                                                                                              2. index_only_evidence_requires_review
                                                                                                                                                                                              verification status
                                                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                                                              2025-11-13 · FDA approves new interchangeable biosimilar to Perjeta
                                                                                                                                                                                              id
                                                                                                                                                                                              fda-5443f7e086270c53
                                                                                                                                                                                              event type
                                                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                                                              event date
                                                                                                                                                                                              2025-11-13
                                                                                                                                                                                              title
                                                                                                                                                                                              FDA approves new interchangeable biosimilar to Perjeta
                                                                                                                                                                                              drug or regimen
                                                                                                                                                                                              pertuzumab-dpzb (Poherdy)
                                                                                                                                                                                              approval date
                                                                                                                                                                                              2025-11-13
                                                                                                                                                                                              approval type
                                                                                                                                                                                              interchangeable biosimilar
                                                                                                                                                                                              approval type evidence
                                                                                                                                                                                              interchangeable biosimilar explicitly stated in title/opening
                                                                                                                                                                                              indication summary
                                                                                                                                                                                              FDA approved Poherdy as an interchangeable biosimilar to Perjeta . This is the first approval of a biosimilar for Perjeta.
                                                                                                                                                                                              indication source text
                                                                                                                                                                                              On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.
                                                                                                                                                                                              opening context blocks
                                                                                                                                                                                              1. On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.
                                                                                                                                                                                              2. Poherdy is a HER2/neu receptor antagonist indicated for the following:
                                                                                                                                                                                              3. use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
                                                                                                                                                                                              4. use in combination with trastuzumab and chemotherapy asneoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
                                                                                                                                                                                              5. neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
                                                                                                                                                                                              6. adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
                                                                                                                                                                                              tumor type mapping hints
                                                                                                                                                                                              1. breast
                                                                                                                                                                                              mapping status
                                                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                                                              regulatory meaning
                                                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                              source url
                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta
                                                                                                                                                                                              evidence source url
                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta
                                                                                                                                                                                              source basis
                                                                                                                                                                                              individual FDA notification page
                                                                                                                                                                                              source locator
                                                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                              index date
                                                                                                                                                                                              2025-11-13
                                                                                                                                                                                              index description
                                                                                                                                                                                              On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.
                                                                                                                                                                                              provenance
                                                                                                                                                                                              retrieved at
                                                                                                                                                                                              2026-09-09T23:22:01.649212+00:00
                                                                                                                                                                                              local html
                                                                                                                                                                                              pages/fda-approves-new-interchangeable-biosimilar-perjeta.html
                                                                                                                                                                                              sha256
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                                                                                                                                                                                              headers file
                                                                                                                                                                                              pages/fda-approves-new-interchangeable-biosimilar-perjeta.headers.txt
                                                                                                                                                                                              full text file
                                                                                                                                                                                              pages/fda-approves-new-interchangeable-biosimilar-perjeta.txt
                                                                                                                                                                                              linked prescribing information
                                                                                                                                                                                                nct ids
                                                                                                                                                                                                  quality flags
                                                                                                                                                                                                    verification status
                                                                                                                                                                                                    source_extracted_not_clinically_reviewed
                                                                                                                                                                                                    2025-11-06 · FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
                                                                                                                                                                                                    id
                                                                                                                                                                                                    fda-ebc8920f637fe1db
                                                                                                                                                                                                    event type
                                                                                                                                                                                                    fda_oncology_approval_notification
                                                                                                                                                                                                    event date
                                                                                                                                                                                                    2025-11-06
                                                                                                                                                                                                    title
                                                                                                                                                                                                    FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
                                                                                                                                                                                                    drug or regimen
                                                                                                                                                                                                    daratumumab and hyaluronidase-fihj
                                                                                                                                                                                                    approval date
                                                                                                                                                                                                    2025-11-06
                                                                                                                                                                                                    approval type
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    approval type evidence
                                                                                                                                                                                                    FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                    indication summary
                                                                                                                                                                                                    FDA approved daratumumab and hyaluronidase-fihj for adults with high-risk smoldering multiple myeloma .
                                                                                                                                                                                                    indication source text
                                                                                                                                                                                                    On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).
                                                                                                                                                                                                    opening context blocks
                                                                                                                                                                                                    1. On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).
                                                                                                                                                                                                    tumor type mapping hints
                                                                                                                                                                                                    1. myeloma
                                                                                                                                                                                                    mapping status
                                                                                                                                                                                                    heuristic_requires_editorial_review
                                                                                                                                                                                                    regulatory meaning
                                                                                                                                                                                                    Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                    source url
                                                                                                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma
                                                                                                                                                                                                    evidence source url
                                                                                                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma
                                                                                                                                                                                                    source basis
                                                                                                                                                                                                    individual FDA notification page
                                                                                                                                                                                                    source locator
                                                                                                                                                                                                    Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                    index date
                                                                                                                                                                                                    2025-11-06
                                                                                                                                                                                                    index description
                                                                                                                                                                                                    On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).
                                                                                                                                                                                                    provenance
                                                                                                                                                                                                    retrieved at
                                                                                                                                                                                                    2026-09-09T23:22:03.263367+00:00
                                                                                                                                                                                                    local html
                                                                                                                                                                                                    pages/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma.html
                                                                                                                                                                                                    sha256
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                                                                                                                                                                                                    headers file
                                                                                                                                                                                                    pages/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma.headers.txt
                                                                                                                                                                                                    full text file
                                                                                                                                                                                                    pages/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma.txt
                                                                                                                                                                                                    linked prescribing information
                                                                                                                                                                                                      nct ids
                                                                                                                                                                                                      1. NCT03301220
                                                                                                                                                                                                      quality flags
                                                                                                                                                                                                        verification status
                                                                                                                                                                                                        source_extracted_not_clinically_reviewed
                                                                                                                                                                                                        2025-10-24 · FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation
                                                                                                                                                                                                        id
                                                                                                                                                                                                        fda-61ed478e73d4f4a0
                                                                                                                                                                                                        event type
                                                                                                                                                                                                        fda_oncology_approval_notification
                                                                                                                                                                                                        event date
                                                                                                                                                                                                        2025-10-24
                                                                                                                                                                                                        title
                                                                                                                                                                                                        FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation
                                                                                                                                                                                                        drug or regimen
                                                                                                                                                                                                        revumenib
                                                                                                                                                                                                        approval date
                                                                                                                                                                                                        2025-10-24
                                                                                                                                                                                                        approval type
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        approval type evidence
                                                                                                                                                                                                        FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                        indication summary
                                                                                                                                                                                                        FDA approved revumenib, a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
                                                                                                                                                                                                        indication source text
                                                                                                                                                                                                        On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
                                                                                                                                                                                                        opening context blocks
                                                                                                                                                                                                        1. On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
                                                                                                                                                                                                        tumor type mapping hints
                                                                                                                                                                                                        1. leukemia
                                                                                                                                                                                                        mapping status
                                                                                                                                                                                                        heuristic_requires_editorial_review
                                                                                                                                                                                                        regulatory meaning
                                                                                                                                                                                                        Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                        source url
                                                                                                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation
                                                                                                                                                                                                        evidence source url
                                                                                                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation
                                                                                                                                                                                                        source basis
                                                                                                                                                                                                        individual FDA notification page
                                                                                                                                                                                                        source locator
                                                                                                                                                                                                        Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                        index date
                                                                                                                                                                                                        2025-10-24
                                                                                                                                                                                                        index description
                                                                                                                                                                                                        On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
                                                                                                                                                                                                        provenance
                                                                                                                                                                                                        retrieved at
                                                                                                                                                                                                        2026-09-09T23:22:04.082634+00:00
                                                                                                                                                                                                        local html
                                                                                                                                                                                                        pages/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation.html
                                                                                                                                                                                                        sha256
                                                                                                                                                                                                        91c035417bea5ef340c7fbf3267fd6d059db4db928df04e7288bc474ae2a207e
                                                                                                                                                                                                        headers file
                                                                                                                                                                                                        pages/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation.headers.txt
                                                                                                                                                                                                        full text file
                                                                                                                                                                                                        pages/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation.txt
                                                                                                                                                                                                        linked prescribing information
                                                                                                                                                                                                          nct ids
                                                                                                                                                                                                          1. NCT04065399
                                                                                                                                                                                                          quality flags
                                                                                                                                                                                                            verification status
                                                                                                                                                                                                            source_extracted_not_clinically_reviewed
                                                                                                                                                                                                            2025-10-23 · FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma
                                                                                                                                                                                                            id
                                                                                                                                                                                                            fda-29d861b96a3e37e4
                                                                                                                                                                                                            event type
                                                                                                                                                                                                            fda_oncology_approval_notification
                                                                                                                                                                                                            event date
                                                                                                                                                                                                            2025-10-23
                                                                                                                                                                                                            title
                                                                                                                                                                                                            FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma
                                                                                                                                                                                                            drug or regimen
                                                                                                                                                                                                            belantamab mafodotin-blmf
                                                                                                                                                                                                            approval date
                                                                                                                                                                                                            2025-10-23
                                                                                                                                                                                                            approval type
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            approval type evidence
                                                                                                                                                                                                            FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                            indication summary
                                                                                                                                                                                                            FDA approved belantamab mafodotin-blmf, a B-cell maturation antigen -directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
                                                                                                                                                                                                            indication source text
                                                                                                                                                                                                            On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
                                                                                                                                                                                                            opening context blocks
                                                                                                                                                                                                            1. On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
                                                                                                                                                                                                            tumor type mapping hints
                                                                                                                                                                                                            1. myeloma
                                                                                                                                                                                                            mapping status
                                                                                                                                                                                                            heuristic_requires_editorial_review
                                                                                                                                                                                                            regulatory meaning
                                                                                                                                                                                                            Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                            source url
                                                                                                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma
                                                                                                                                                                                                            evidence source url
                                                                                                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma
                                                                                                                                                                                                            source basis
                                                                                                                                                                                                            individual FDA notification page
                                                                                                                                                                                                            source locator
                                                                                                                                                                                                            Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                            index date
                                                                                                                                                                                                            2025-10-23
                                                                                                                                                                                                            index description
                                                                                                                                                                                                            On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
                                                                                                                                                                                                            provenance
                                                                                                                                                                                                            retrieved at
                                                                                                                                                                                                            2026-09-09T23:22:05.338635+00:00
                                                                                                                                                                                                            local html
                                                                                                                                                                                                            pages/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma.html
                                                                                                                                                                                                            sha256
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                                                                                                                                                                                                            pages/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma.txt
                                                                                                                                                                                                            linked prescribing information
                                                                                                                                                                                                              nct ids
                                                                                                                                                                                                              1. NCT04246047
                                                                                                                                                                                                              quality flags
                                                                                                                                                                                                                verification status
                                                                                                                                                                                                                source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                2025-10-08 · FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma
                                                                                                                                                                                                                id
                                                                                                                                                                                                                fda-b93fc8a06f72822f
                                                                                                                                                                                                                event type
                                                                                                                                                                                                                fda_oncology_approval_notification
                                                                                                                                                                                                                event date
                                                                                                                                                                                                                2025-10-08
                                                                                                                                                                                                                title
                                                                                                                                                                                                                FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma
                                                                                                                                                                                                                drug or regimen
                                                                                                                                                                                                                cemiplimab-rwlc
                                                                                                                                                                                                                approval date
                                                                                                                                                                                                                2025-10-08
                                                                                                                                                                                                                approval type
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                approval type evidence
                                                                                                                                                                                                                FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                indication summary
                                                                                                                                                                                                                FDA approved cemiplimab-rwlc for the adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
                                                                                                                                                                                                                indication source text
                                                                                                                                                                                                                On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
                                                                                                                                                                                                                opening context blocks
                                                                                                                                                                                                                1. On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
                                                                                                                                                                                                                tumor type mapping hints
                                                                                                                                                                                                                1. cutaneous-squamous-cell
                                                                                                                                                                                                                mapping status
                                                                                                                                                                                                                heuristic_requires_editorial_review
                                                                                                                                                                                                                regulatory meaning
                                                                                                                                                                                                                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                source url
                                                                                                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma
                                                                                                                                                                                                                evidence source url
                                                                                                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma
                                                                                                                                                                                                                source basis
                                                                                                                                                                                                                individual FDA notification page
                                                                                                                                                                                                                source locator
                                                                                                                                                                                                                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                index date
                                                                                                                                                                                                                2025-10-08
                                                                                                                                                                                                                index description
                                                                                                                                                                                                                On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
                                                                                                                                                                                                                provenance
                                                                                                                                                                                                                retrieved at
                                                                                                                                                                                                                2026-09-09T23:22:06.182456+00:00
                                                                                                                                                                                                                local html
                                                                                                                                                                                                                pages/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma.html
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                                                                                                                                                                                                                full text file
                                                                                                                                                                                                                pages/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma.txt
                                                                                                                                                                                                                linked prescribing information
                                                                                                                                                                                                                  nct ids
                                                                                                                                                                                                                  1. NCT03969004
                                                                                                                                                                                                                  quality flags
                                                                                                                                                                                                                    verification status
                                                                                                                                                                                                                    source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                    2025-10-02 · FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer
                                                                                                                                                                                                                    id
                                                                                                                                                                                                                    fda-2552276b0d3a31f8
                                                                                                                                                                                                                    event type
                                                                                                                                                                                                                    fda_oncology_approval_notification
                                                                                                                                                                                                                    event date
                                                                                                                                                                                                                    2025-10-02
                                                                                                                                                                                                                    title
                                                                                                                                                                                                                    FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer
                                                                                                                                                                                                                    drug or regimen
                                                                                                                                                                                                                    lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs
                                                                                                                                                                                                                    approval date
                                                                                                                                                                                                                    2025-10-02
                                                                                                                                                                                                                    approval type
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    approval type evidence
                                                                                                                                                                                                                    FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                    indication summary
                                                                                                                                                                                                                    FDA approved lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.
                                                                                                                                                                                                                    indication source text
                                                                                                                                                                                                                    On October 2, 2025, the Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.
                                                                                                                                                                                                                    opening context blocks
                                                                                                                                                                                                                    1. On October 2, 2025, the Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.
                                                                                                                                                                                                                    tumor type mapping hints
                                                                                                                                                                                                                    1. lung
                                                                                                                                                                                                                    mapping status
                                                                                                                                                                                                                    heuristic_requires_editorial_review
                                                                                                                                                                                                                    regulatory meaning
                                                                                                                                                                                                                    Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                    source url
                                                                                                                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive
                                                                                                                                                                                                                    evidence source url
                                                                                                                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive
                                                                                                                                                                                                                    source basis
                                                                                                                                                                                                                    individual FDA notification page
                                                                                                                                                                                                                    source locator
                                                                                                                                                                                                                    Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                    index date
                                                                                                                                                                                                                    2025-10-02
                                                                                                                                                                                                                    index description
                                                                                                                                                                                                                    On October 2, 2025, the Food and Drug Administration approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals, Inc.) in combination with atezolizumab (Tecentriq, Genentech Inc.) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech Inc.) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.
                                                                                                                                                                                                                    provenance
                                                                                                                                                                                                                    retrieved at
                                                                                                                                                                                                                    2026-09-09T23:22:07.135199+00:00
                                                                                                                                                                                                                    local html
                                                                                                                                                                                                                    pages/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive.html
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                                                                                                                                                                                                                    full text file
                                                                                                                                                                                                                    pages/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive.txt
                                                                                                                                                                                                                    linked prescribing information
                                                                                                                                                                                                                      nct ids
                                                                                                                                                                                                                      1. NCT05091567
                                                                                                                                                                                                                      quality flags
                                                                                                                                                                                                                        verification status
                                                                                                                                                                                                                        source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                        2025-09-25 · FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
                                                                                                                                                                                                                        id
                                                                                                                                                                                                                        fda-e6329c4a9f1a5704
                                                                                                                                                                                                                        event type
                                                                                                                                                                                                                        fda_oncology_approval_notification
                                                                                                                                                                                                                        event date
                                                                                                                                                                                                                        2025-09-25
                                                                                                                                                                                                                        title
                                                                                                                                                                                                                        FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
                                                                                                                                                                                                                        drug or regimen
                                                                                                                                                                                                                        imlunestrant
                                                                                                                                                                                                                        approval date
                                                                                                                                                                                                                        2025-09-25
                                                                                                                                                                                                                        approval type
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        approval type evidence
                                                                                                                                                                                                                        FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                        indication summary
                                                                                                                                                                                                                        FDA approved imlunestrant, an estrogen receptor antagonist, for adults with estrogen receptor -positive, human epidermal growth factor 2 -negative, estrogen receptor-1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
                                                                                                                                                                                                                        indication source text
                                                                                                                                                                                                                        On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
                                                                                                                                                                                                                        opening context blocks
                                                                                                                                                                                                                        1. On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
                                                                                                                                                                                                                        2. FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with imlunestrant.
                                                                                                                                                                                                                        tumor type mapping hints
                                                                                                                                                                                                                        1. breast
                                                                                                                                                                                                                        mapping status
                                                                                                                                                                                                                        heuristic_requires_editorial_review
                                                                                                                                                                                                                        regulatory meaning
                                                                                                                                                                                                                        Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast
                                                                                                                                                                                                                        evidence source url
                                                                                                                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast
                                                                                                                                                                                                                        source basis
                                                                                                                                                                                                                        individual FDA notification page
                                                                                                                                                                                                                        source locator
                                                                                                                                                                                                                        Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                        index date
                                                                                                                                                                                                                        2025-09-25
                                                                                                                                                                                                                        index description
                                                                                                                                                                                                                        On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
                                                                                                                                                                                                                        provenance
                                                                                                                                                                                                                        retrieved at
                                                                                                                                                                                                                        2026-09-09T23:22:08.196800+00:00
                                                                                                                                                                                                                        local html
                                                                                                                                                                                                                        pages/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast.html
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                                                                                                                                                                                                                        full text file
                                                                                                                                                                                                                        pages/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast.txt
                                                                                                                                                                                                                        linked prescribing information
                                                                                                                                                                                                                          nct ids
                                                                                                                                                                                                                          1. NCT04975308
                                                                                                                                                                                                                          quality flags
                                                                                                                                                                                                                            verification status
                                                                                                                                                                                                                            source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                            2025-09-19 · FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection
                                                                                                                                                                                                                            id
                                                                                                                                                                                                                            fda-7c04bb055e3ac31c
                                                                                                                                                                                                                            event type
                                                                                                                                                                                                                            fda_oncology_approval_notification
                                                                                                                                                                                                                            event date
                                                                                                                                                                                                                            2025-09-19
                                                                                                                                                                                                                            title
                                                                                                                                                                                                                            FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection
                                                                                                                                                                                                                            drug or regimen
                                                                                                                                                                                                                            pembrolizumab and berahyaluronidase alfa-pmph
                                                                                                                                                                                                                            approval date
                                                                                                                                                                                                                            2025-09-19
                                                                                                                                                                                                                            approval type
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            approval type evidence
                                                                                                                                                                                                                            FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                            indication summary
                                                                                                                                                                                                                            FDA approved pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection for adult and pediatric solid tumor indications approved for the intravenous formulation of pembrolizumab . See the prescribing information for the specific indications.
                                                                                                                                                                                                                            indication source text
                                                                                                                                                                                                                            On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck). See the prescribing information for the specific indications.
                                                                                                                                                                                                                            opening context blocks
                                                                                                                                                                                                                            1. On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck). See the prescribing information for the specific indications.
                                                                                                                                                                                                                            tumor type mapping hints
                                                                                                                                                                                                                            1. solid-tumors
                                                                                                                                                                                                                            mapping status
                                                                                                                                                                                                                            heuristic_requires_editorial_review
                                                                                                                                                                                                                            regulatory meaning
                                                                                                                                                                                                                            Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                            source url
                                                                                                                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection
                                                                                                                                                                                                                            evidence source url
                                                                                                                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection
                                                                                                                                                                                                                            source basis
                                                                                                                                                                                                                            individual FDA notification page
                                                                                                                                                                                                                            source locator
                                                                                                                                                                                                                            Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                            index date
                                                                                                                                                                                                                            2025-09-19
                                                                                                                                                                                                                            index description
                                                                                                                                                                                                                            On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck). See the prescribing information for the specific indications.
                                                                                                                                                                                                                            provenance
                                                                                                                                                                                                                            retrieved at
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                                                                                                                                                                                                                            pages/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection.headers.txt
                                                                                                                                                                                                                            full text file
                                                                                                                                                                                                                            pages/fda-approves-pembrolizumab-and-berahyaluronidase-alfa-pmph-subcutaneous-injection.txt
                                                                                                                                                                                                                            linked prescribing information
                                                                                                                                                                                                                              nct ids
                                                                                                                                                                                                                              1. NCT05722015
                                                                                                                                                                                                                              quality flags
                                                                                                                                                                                                                              1. possible_multiple_indications_review
                                                                                                                                                                                                                              verification status
                                                                                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                              2025-09-10 · FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
                                                                                                                                                                                                                              id
                                                                                                                                                                                                                              fda-9327c9c5fe816ed3
                                                                                                                                                                                                                              event type
                                                                                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                                                                                              event date
                                                                                                                                                                                                                              2025-09-10
                                                                                                                                                                                                                              title
                                                                                                                                                                                                                              FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
                                                                                                                                                                                                                              drug or regimen
                                                                                                                                                                                                                              selumetinib
                                                                                                                                                                                                                              approval date
                                                                                                                                                                                                                              2025-09-10
                                                                                                                                                                                                                              approval type
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              approval type evidence
                                                                                                                                                                                                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                              indication summary
                                                                                                                                                                                                                              FDA approved selumetinib granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas . FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.
                                                                                                                                                                                                                              indication source text
                                                                                                                                                                                                                              On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.
                                                                                                                                                                                                                              opening context blocks
                                                                                                                                                                                                                              1. On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.
                                                                                                                                                                                                                              tumor type mapping hints
                                                                                                                                                                                                                              1. neurofibromatosis
                                                                                                                                                                                                                              mapping status
                                                                                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                                                                                              regulatory meaning
                                                                                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1
                                                                                                                                                                                                                              evidence source url
                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1
                                                                                                                                                                                                                              source basis
                                                                                                                                                                                                                              individual FDA notification page
                                                                                                                                                                                                                              source locator
                                                                                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                              index date
                                                                                                                                                                                                                              2025-09-10
                                                                                                                                                                                                                              index description
                                                                                                                                                                                                                              On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.
                                                                                                                                                                                                                              provenance
                                                                                                                                                                                                                              retrieved at
                                                                                                                                                                                                                              2026-09-09T23:22:10.367937+00:00
                                                                                                                                                                                                                              local html
                                                                                                                                                                                                                              pages/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1.html
                                                                                                                                                                                                                              sha256
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                                                                                                                                                                                                                              headers file
                                                                                                                                                                                                                              pages/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1.headers.txt
                                                                                                                                                                                                                              full text file
                                                                                                                                                                                                                              pages/fda-approves-selumetinib-pediatric-patients-1-year-age-and-older-neurofibromatosis-type-1.txt
                                                                                                                                                                                                                              linked prescribing information
                                                                                                                                                                                                                                nct ids
                                                                                                                                                                                                                                  quality flags
                                                                                                                                                                                                                                  1. may_be_supportive_care_or_nonmalignant_condition
                                                                                                                                                                                                                                  verification status
                                                                                                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                  2025-09-09 · FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                  fda-a71e076b93797c1c
                                                                                                                                                                                                                                  event type
                                                                                                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                                                                                                  event date
                                                                                                                                                                                                                                  2025-09-09
                                                                                                                                                                                                                                  title
                                                                                                                                                                                                                                  FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
                                                                                                                                                                                                                                  drug or regimen
                                                                                                                                                                                                                                  gemcitabine intravesical system
                                                                                                                                                                                                                                  approval date
                                                                                                                                                                                                                                  2025-09-09
                                                                                                                                                                                                                                  approval type
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  approval type evidence
                                                                                                                                                                                                                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                  indication summary
                                                                                                                                                                                                                                  FDA approved gemcitabine intravesical system for adults with Bacillus Calmette-Guérin -unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.
                                                                                                                                                                                                                                  indication source text
                                                                                                                                                                                                                                  On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.
                                                                                                                                                                                                                                  opening context blocks
                                                                                                                                                                                                                                  1. On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.
                                                                                                                                                                                                                                  tumor type mapping hints
                                                                                                                                                                                                                                  1. bladder
                                                                                                                                                                                                                                  mapping status
                                                                                                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                                                                                                  regulatory meaning
                                                                                                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer
                                                                                                                                                                                                                                  evidence source url
                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer
                                                                                                                                                                                                                                  source basis
                                                                                                                                                                                                                                  individual FDA notification page
                                                                                                                                                                                                                                  source locator
                                                                                                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                  index date
                                                                                                                                                                                                                                  2025-09-09
                                                                                                                                                                                                                                  index description
                                                                                                                                                                                                                                  On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.
                                                                                                                                                                                                                                  provenance
                                                                                                                                                                                                                                  retrieved at
                                                                                                                                                                                                                                  2026-09-09T23:22:11.296206+00:00
                                                                                                                                                                                                                                  local html
                                                                                                                                                                                                                                  pages/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer.html
                                                                                                                                                                                                                                  sha256
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                                                                                                                                                                                                                                  headers file
                                                                                                                                                                                                                                  pages/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer.headers.txt
                                                                                                                                                                                                                                  full text file
                                                                                                                                                                                                                                  pages/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer.txt
                                                                                                                                                                                                                                  linked prescribing information
                                                                                                                                                                                                                                    nct ids
                                                                                                                                                                                                                                    1. NCT04640623
                                                                                                                                                                                                                                    quality flags
                                                                                                                                                                                                                                      verification status
                                                                                                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                      2025-08-08 · FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations
                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                      fda-7d091a8440ce03e5
                                                                                                                                                                                                                                      event type
                                                                                                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                                                                                                      event date
                                                                                                                                                                                                                                      2025-08-08
                                                                                                                                                                                                                                      title
                                                                                                                                                                                                                                      FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations
                                                                                                                                                                                                                                      drug or regimen
                                                                                                                                                                                                                                      zongertinib
                                                                                                                                                                                                                                      approval date
                                                                                                                                                                                                                                      2025-08-08
                                                                                                                                                                                                                                      approval type
                                                                                                                                                                                                                                      accelerated
                                                                                                                                                                                                                                      approval type evidence
                                                                                                                                                                                                                                      accelerated explicitly stated in title/opening
                                                                                                                                                                                                                                      indication summary
                                                                                                                                                                                                                                      FDA approved zongertinib, a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
                                                                                                                                                                                                                                      indication source text
                                                                                                                                                                                                                                      On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
                                                                                                                                                                                                                                      opening context blocks
                                                                                                                                                                                                                                      1. On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
                                                                                                                                                                                                                                      2. FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with zongertinib.
                                                                                                                                                                                                                                      tumor type mapping hints
                                                                                                                                                                                                                                      1. lung
                                                                                                                                                                                                                                      mapping status
                                                                                                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                                                                                                      regulatory meaning
                                                                                                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations
                                                                                                                                                                                                                                      evidence source url
                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations
                                                                                                                                                                                                                                      source basis
                                                                                                                                                                                                                                      individual FDA notification page
                                                                                                                                                                                                                                      source locator
                                                                                                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                      index date
                                                                                                                                                                                                                                      2025-08-08
                                                                                                                                                                                                                                      index description
                                                                                                                                                                                                                                      On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
                                                                                                                                                                                                                                      provenance
                                                                                                                                                                                                                                      retrieved at
                                                                                                                                                                                                                                      2026-09-09T23:22:12.313471+00:00
                                                                                                                                                                                                                                      local html
                                                                                                                                                                                                                                      pages/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations.html
                                                                                                                                                                                                                                      sha256
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                                                                                                                                                                                                                                      headers file
                                                                                                                                                                                                                                      pages/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations.headers.txt
                                                                                                                                                                                                                                      full text file
                                                                                                                                                                                                                                      pages/fda-grants-accelerated-approval-zongertinib-non-squamous-nsclc-her2-tkd-activating-mutations.txt
                                                                                                                                                                                                                                      linked prescribing information
                                                                                                                                                                                                                                        nct ids
                                                                                                                                                                                                                                        1. NCT04886804
                                                                                                                                                                                                                                        quality flags
                                                                                                                                                                                                                                          verification status
                                                                                                                                                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                          2025-08-06 · FDA grants accelerated approval to dordaviprone for diffuse midline glioma
                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                          fda-a3a29918b1e0c594
                                                                                                                                                                                                                                          event type
                                                                                                                                                                                                                                          fda_oncology_approval_notification
                                                                                                                                                                                                                                          event date
                                                                                                                                                                                                                                          2025-08-06
                                                                                                                                                                                                                                          title
                                                                                                                                                                                                                                          FDA grants accelerated approval to dordaviprone for diffuse midline glioma
                                                                                                                                                                                                                                          drug or regimen
                                                                                                                                                                                                                                          dordaviprone
                                                                                                                                                                                                                                          approval date
                                                                                                                                                                                                                                          2025-08-06
                                                                                                                                                                                                                                          approval type
                                                                                                                                                                                                                                          accelerated
                                                                                                                                                                                                                                          approval type evidence
                                                                                                                                                                                                                                          accelerated explicitly stated in title/opening
                                                                                                                                                                                                                                          indication summary
                                                                                                                                                                                                                                          FDA approved dordaviprone, a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
                                                                                                                                                                                                                                          indication source text
                                                                                                                                                                                                                                          On August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
                                                                                                                                                                                                                                          opening context blocks
                                                                                                                                                                                                                                          1. On August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
                                                                                                                                                                                                                                          2. This represents the first FDA approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma.
                                                                                                                                                                                                                                          tumor type mapping hints
                                                                                                                                                                                                                                          1. glioma
                                                                                                                                                                                                                                          mapping status
                                                                                                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                                                                                                          regulatory meaning
                                                                                                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma
                                                                                                                                                                                                                                          evidence source url
                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma
                                                                                                                                                                                                                                          source basis
                                                                                                                                                                                                                                          individual FDA notification page
                                                                                                                                                                                                                                          source locator
                                                                                                                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                          index date
                                                                                                                                                                                                                                          2025-08-06
                                                                                                                                                                                                                                          index description
                                                                                                                                                                                                                                          On August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
                                                                                                                                                                                                                                          provenance
                                                                                                                                                                                                                                          retrieved at
                                                                                                                                                                                                                                          2026-09-09T23:22:13.146799+00:00
                                                                                                                                                                                                                                          local html
                                                                                                                                                                                                                                          pages/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma.html
                                                                                                                                                                                                                                          sha256
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                                                                                                                                                                                                                                          headers file
                                                                                                                                                                                                                                          pages/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma.headers.txt
                                                                                                                                                                                                                                          full text file
                                                                                                                                                                                                                                          pages/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma.txt
                                                                                                                                                                                                                                          linked prescribing information
                                                                                                                                                                                                                                            nct ids
                                                                                                                                                                                                                                            1. NCT02525692
                                                                                                                                                                                                                                            2. NCT03134131
                                                                                                                                                                                                                                            3. NCT03295396
                                                                                                                                                                                                                                            4. NCT03416530
                                                                                                                                                                                                                                            5. NCT05392374
                                                                                                                                                                                                                                            quality flags
                                                                                                                                                                                                                                              verification status
                                                                                                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                              2025-07-02 · FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
                                                                                                                                                                                                                                              id
                                                                                                                                                                                                                                              fda-29a56844a8ee9ae3
                                                                                                                                                                                                                                              event type
                                                                                                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                                                                                                              event date
                                                                                                                                                                                                                                              2025-07-02
                                                                                                                                                                                                                                              title
                                                                                                                                                                                                                                              FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
                                                                                                                                                                                                                                              drug or regimen
                                                                                                                                                                                                                                              sunvozertinib
                                                                                                                                                                                                                                              approval date
                                                                                                                                                                                                                                              2025-07-02
                                                                                                                                                                                                                                              approval type
                                                                                                                                                                                                                                              accelerated
                                                                                                                                                                                                                                              approval type evidence
                                                                                                                                                                                                                                              accelerated explicitly stated in title/opening
                                                                                                                                                                                                                                              indication summary
                                                                                                                                                                                                                                              FDA approved sunvozertinib for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
                                                                                                                                                                                                                                              indication source text
                                                                                                                                                                                                                                              On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
                                                                                                                                                                                                                                              opening context blocks
                                                                                                                                                                                                                                              1. On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
                                                                                                                                                                                                                                              2. Today, FDA also approved the Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting EGFR exon 20 insertion mutations in patients with NSCLC who may be eligible for treatment with Zegfrovy.
                                                                                                                                                                                                                                              tumor type mapping hints
                                                                                                                                                                                                                                              1. lung
                                                                                                                                                                                                                                              mapping status
                                                                                                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                                                                                                              regulatory meaning
                                                                                                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20
                                                                                                                                                                                                                                              evidence source url
                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20
                                                                                                                                                                                                                                              source basis
                                                                                                                                                                                                                                              individual FDA notification page
                                                                                                                                                                                                                                              source locator
                                                                                                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                              index date
                                                                                                                                                                                                                                              2025-07-02
                                                                                                                                                                                                                                              index description
                                                                                                                                                                                                                                              On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
                                                                                                                                                                                                                                              provenance
                                                                                                                                                                                                                                              retrieved at
                                                                                                                                                                                                                                              2026-09-09T23:22:14.149511+00:00
                                                                                                                                                                                                                                              local html
                                                                                                                                                                                                                                              pages/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20.html
                                                                                                                                                                                                                                              sha256
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                                                                                                                                                                                                                                              headers file
                                                                                                                                                                                                                                              pages/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20.headers.txt
                                                                                                                                                                                                                                              full text file
                                                                                                                                                                                                                                              pages/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20.txt
                                                                                                                                                                                                                                              linked prescribing information
                                                                                                                                                                                                                                                nct ids
                                                                                                                                                                                                                                                1. NCT03974022
                                                                                                                                                                                                                                                quality flags
                                                                                                                                                                                                                                                  verification status
                                                                                                                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                  2025-07-02 · FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma
                                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                                  fda-20922be08c90e6ba
                                                                                                                                                                                                                                                  event type
                                                                                                                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                                                                                                                  event date
                                                                                                                                                                                                                                                  2025-07-02
                                                                                                                                                                                                                                                  title
                                                                                                                                                                                                                                                  FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma
                                                                                                                                                                                                                                                  drug or regimen
                                                                                                                                                                                                                                                  linvoseltamab-gcpt
                                                                                                                                                                                                                                                  approval date
                                                                                                                                                                                                                                                  2025-07-02
                                                                                                                                                                                                                                                  approval type
                                                                                                                                                                                                                                                  accelerated
                                                                                                                                                                                                                                                  approval type evidence
                                                                                                                                                                                                                                                  accelerated explicitly stated in title/opening
                                                                                                                                                                                                                                                  indication summary
                                                                                                                                                                                                                                                  FDA approved linvoseltamab-gcpt, a bispecific B-cell maturation antigen -directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
                                                                                                                                                                                                                                                  indication source text
                                                                                                                                                                                                                                                  On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.
                                                                                                                                                                                                                                                  opening context blocks
                                                                                                                                                                                                                                                  1. On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.
                                                                                                                                                                                                                                                  tumor type mapping hints
                                                                                                                                                                                                                                                  1. myeloma
                                                                                                                                                                                                                                                  mapping status
                                                                                                                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                                                                                                                  regulatory meaning
                                                                                                                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma
                                                                                                                                                                                                                                                  evidence source url
                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma
                                                                                                                                                                                                                                                  source basis
                                                                                                                                                                                                                                                  individual FDA notification page
                                                                                                                                                                                                                                                  source locator
                                                                                                                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                  index date
                                                                                                                                                                                                                                                  2025-07-02
                                                                                                                                                                                                                                                  index description
                                                                                                                                                                                                                                                  On July 2, 2025, the Food and Drug Administration granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.
                                                                                                                                                                                                                                                  provenance
                                                                                                                                                                                                                                                  retrieved at
                                                                                                                                                                                                                                                  2026-09-09T23:22:15.225862+00:00
                                                                                                                                                                                                                                                  local html
                                                                                                                                                                                                                                                  pages/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma.html
                                                                                                                                                                                                                                                  sha256
                                                                                                                                                                                                                                                  0382ef10d5951667eba1c5dab7df1adaa18dd66d19ddd689402b273fb90f78a0
                                                                                                                                                                                                                                                  headers file
                                                                                                                                                                                                                                                  pages/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma.headers.txt
                                                                                                                                                                                                                                                  full text file
                                                                                                                                                                                                                                                  pages/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma.txt
                                                                                                                                                                                                                                                  linked prescribing information
                                                                                                                                                                                                                                                    nct ids
                                                                                                                                                                                                                                                    1. NCT03761108
                                                                                                                                                                                                                                                    quality flags
                                                                                                                                                                                                                                                      verification status
                                                                                                                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                      2025-06-23 · FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
                                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                                      fda-29743855ffd67cd9
                                                                                                                                                                                                                                                      event type
                                                                                                                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                                                                                                                      event date
                                                                                                                                                                                                                                                      2025-06-23
                                                                                                                                                                                                                                                      title
                                                                                                                                                                                                                                                      FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
                                                                                                                                                                                                                                                      drug or regimen
                                                                                                                                                                                                                                                      datopotamab deruxtecan-dlnk
                                                                                                                                                                                                                                                      approval date
                                                                                                                                                                                                                                                      2025-06-23
                                                                                                                                                                                                                                                      approval type
                                                                                                                                                                                                                                                      accelerated
                                                                                                                                                                                                                                                      approval type evidence
                                                                                                                                                                                                                                                      accelerated explicitly stated in title/opening
                                                                                                                                                                                                                                                      indication summary
                                                                                                                                                                                                                                                      FDA approved datopotamab deruxtecan-dlnk for adults with locally advanced or metastatic epidermal growth factor receptor -mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.
                                                                                                                                                                                                                                                      indication source text
                                                                                                                                                                                                                                                      On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
                                                                                                                                                                                                                                                      opening context blocks
                                                                                                                                                                                                                                                      1. On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
                                                                                                                                                                                                                                                      tumor type mapping hints
                                                                                                                                                                                                                                                      1. lung
                                                                                                                                                                                                                                                      mapping status
                                                                                                                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                                                                                                                      regulatory meaning
                                                                                                                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer
                                                                                                                                                                                                                                                      evidence source url
                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer
                                                                                                                                                                                                                                                      source basis
                                                                                                                                                                                                                                                      individual FDA notification page
                                                                                                                                                                                                                                                      source locator
                                                                                                                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                      index date
                                                                                                                                                                                                                                                      2025-06-23
                                                                                                                                                                                                                                                      index description
                                                                                                                                                                                                                                                      On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
                                                                                                                                                                                                                                                      provenance
                                                                                                                                                                                                                                                      retrieved at
                                                                                                                                                                                                                                                      2026-09-09T23:22:16.262451+00:00
                                                                                                                                                                                                                                                      local html
                                                                                                                                                                                                                                                      pages/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer.html
                                                                                                                                                                                                                                                      sha256
                                                                                                                                                                                                                                                      d23c7d0cb49d26cffe40b7ca5585cf76bc08c0b1ce0af7fa9b63637f973c1052
                                                                                                                                                                                                                                                      headers file
                                                                                                                                                                                                                                                      pages/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer.headers.txt
                                                                                                                                                                                                                                                      full text file
                                                                                                                                                                                                                                                      pages/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer.txt
                                                                                                                                                                                                                                                      linked prescribing information
                                                                                                                                                                                                                                                        nct ids
                                                                                                                                                                                                                                                        1. NCT04484142
                                                                                                                                                                                                                                                        2. NCT04656652
                                                                                                                                                                                                                                                        quality flags
                                                                                                                                                                                                                                                          verification status
                                                                                                                                                                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                          2025-06-18 · FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
                                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                                          fda-fb6075995c0aa4db
                                                                                                                                                                                                                                                          event type
                                                                                                                                                                                                                                                          fda_oncology_approval_notification
                                                                                                                                                                                                                                                          event date
                                                                                                                                                                                                                                                          2025-06-18
                                                                                                                                                                                                                                                          title
                                                                                                                                                                                                                                                          FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
                                                                                                                                                                                                                                                          drug or regimen
                                                                                                                                                                                                                                                          tafasitamab-cxix
                                                                                                                                                                                                                                                          approval date
                                                                                                                                                                                                                                                          2025-06-18
                                                                                                                                                                                                                                                          approval type
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          approval type evidence
                                                                                                                                                                                                                                                          FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                          indication summary
                                                                                                                                                                                                                                                          FDA approved tafasitamab-cxix with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma .
                                                                                                                                                                                                                                                          indication source text
                                                                                                                                                                                                                                                          On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).
                                                                                                                                                                                                                                                          opening context blocks
                                                                                                                                                                                                                                                          1. On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).
                                                                                                                                                                                                                                                          tumor type mapping hints
                                                                                                                                                                                                                                                          1. lymphoma
                                                                                                                                                                                                                                                          mapping status
                                                                                                                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                                                                                                                          regulatory meaning
                                                                                                                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
                                                                                                                                                                                                                                                          evidence source url
                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
                                                                                                                                                                                                                                                          source basis
                                                                                                                                                                                                                                                          individual FDA notification page
                                                                                                                                                                                                                                                          source locator
                                                                                                                                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                          index date
                                                                                                                                                                                                                                                          2025-06-18
                                                                                                                                                                                                                                                          index description
                                                                                                                                                                                                                                                          On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).
                                                                                                                                                                                                                                                          provenance
                                                                                                                                                                                                                                                          retrieved at
                                                                                                                                                                                                                                                          2026-09-09T23:22:17.236504+00:00
                                                                                                                                                                                                                                                          local html
                                                                                                                                                                                                                                                          pages/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma.html
                                                                                                                                                                                                                                                          sha256
                                                                                                                                                                                                                                                          d9c2b9b0c5773c0d49b6c0155afedefe23d3e73b96107a9592919e644a014569
                                                                                                                                                                                                                                                          headers file
                                                                                                                                                                                                                                                          pages/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma.headers.txt
                                                                                                                                                                                                                                                          full text file
                                                                                                                                                                                                                                                          pages/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma.txt
                                                                                                                                                                                                                                                          linked prescribing information
                                                                                                                                                                                                                                                            nct ids
                                                                                                                                                                                                                                                            1. NCT04680052
                                                                                                                                                                                                                                                            quality flags
                                                                                                                                                                                                                                                              verification status
                                                                                                                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                              2025-06-12 · FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
                                                                                                                                                                                                                                                              id
                                                                                                                                                                                                                                                              fda-9dafa5ab92723dbc
                                                                                                                                                                                                                                                              event type
                                                                                                                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                                                                                                                              event date
                                                                                                                                                                                                                                                              2025-06-12
                                                                                                                                                                                                                                                              title
                                                                                                                                                                                                                                                              FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
                                                                                                                                                                                                                                                              drug or regimen
                                                                                                                                                                                                                                                              neoadjuvant and adjuvant pembrolizumab
                                                                                                                                                                                                                                                              approval date
                                                                                                                                                                                                                                                              2025-06-12
                                                                                                                                                                                                                                                              approval type
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              approval type evidence
                                                                                                                                                                                                                                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                              indication summary
                                                                                                                                                                                                                                                              FDA approved pembrolizumab for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 [Combined Positive Score ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery, and then as a single agent.
                                                                                                                                                                                                                                                              indication source text
                                                                                                                                                                                                                                                              On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent.
                                                                                                                                                                                                                                                              opening context blocks
                                                                                                                                                                                                                                                              1. On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent.
                                                                                                                                                                                                                                                              2. This is the first approval for HNSCC in 6 years and the first overall perioperative approval for locally advanced HNSCC.
                                                                                                                                                                                                                                                              tumor type mapping hints
                                                                                                                                                                                                                                                              1. head-and-neck
                                                                                                                                                                                                                                                              mapping status
                                                                                                                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                                                                                                                              regulatory meaning
                                                                                                                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck
                                                                                                                                                                                                                                                              evidence source url
                                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck
                                                                                                                                                                                                                                                              source basis
                                                                                                                                                                                                                                                              individual FDA notification page
                                                                                                                                                                                                                                                              source locator
                                                                                                                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                              index date
                                                                                                                                                                                                                                                              2025-06-12
                                                                                                                                                                                                                                                              index description
                                                                                                                                                                                                                                                              On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin after surgery, and then as a single agent.
                                                                                                                                                                                                                                                              provenance
                                                                                                                                                                                                                                                              retrieved at
                                                                                                                                                                                                                                                              2026-09-09T23:22:18.864358+00:00
                                                                                                                                                                                                                                                              local html
                                                                                                                                                                                                                                                              pages/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck.html
                                                                                                                                                                                                                                                              sha256
                                                                                                                                                                                                                                                              da8cf208f7ba628a7082663a873ee60a0376c8bc81671b40f5ca1d81fe9fa2a5
                                                                                                                                                                                                                                                              headers file
                                                                                                                                                                                                                                                              pages/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck.headers.txt
                                                                                                                                                                                                                                                              full text file
                                                                                                                                                                                                                                                              pages/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck.txt
                                                                                                                                                                                                                                                              linked prescribing information
                                                                                                                                                                                                                                                                nct ids
                                                                                                                                                                                                                                                                1. NCT03765918
                                                                                                                                                                                                                                                                quality flags
                                                                                                                                                                                                                                                                  verification status
                                                                                                                                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                  2025-06-12 · FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
                                                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                                                  fda-4ef07a829e92c511
                                                                                                                                                                                                                                                                  event type
                                                                                                                                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                                                                                                                                  event date
                                                                                                                                                                                                                                                                  2025-06-12
                                                                                                                                                                                                                                                                  title
                                                                                                                                                                                                                                                                  FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
                                                                                                                                                                                                                                                                  drug or regimen
                                                                                                                                                                                                                                                                  mitomycin intravesical solution
                                                                                                                                                                                                                                                                  approval date
                                                                                                                                                                                                                                                                  2025-06-12
                                                                                                                                                                                                                                                                  approval type
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  approval type evidence
                                                                                                                                                                                                                                                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                  indication summary
                                                                                                                                                                                                                                                                  FDA approved mitomycin intravesical solution for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer .
                                                                                                                                                                                                                                                                  indication source text
                                                                                                                                                                                                                                                                  On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
                                                                                                                                                                                                                                                                  opening context blocks
                                                                                                                                                                                                                                                                  1. On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
                                                                                                                                                                                                                                                                  tumor type mapping hints
                                                                                                                                                                                                                                                                  1. bladder
                                                                                                                                                                                                                                                                  mapping status
                                                                                                                                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                  regulatory meaning
                                                                                                                                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle
                                                                                                                                                                                                                                                                  evidence source url
                                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle
                                                                                                                                                                                                                                                                  source basis
                                                                                                                                                                                                                                                                  individual FDA notification page
                                                                                                                                                                                                                                                                  source locator
                                                                                                                                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                  index date
                                                                                                                                                                                                                                                                  2025-06-12
                                                                                                                                                                                                                                                                  index description
                                                                                                                                                                                                                                                                  On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
                                                                                                                                                                                                                                                                  provenance
                                                                                                                                                                                                                                                                  retrieved at
                                                                                                                                                                                                                                                                  2026-09-09T23:22:19.438936+00:00
                                                                                                                                                                                                                                                                  local html
                                                                                                                                                                                                                                                                  pages/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle.html
                                                                                                                                                                                                                                                                  sha256
                                                                                                                                                                                                                                                                  703563e1129dc070dadbdb4530ab5d1d1acb271a654f9748741690961c3d7e59
                                                                                                                                                                                                                                                                  headers file
                                                                                                                                                                                                                                                                  pages/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle.headers.txt
                                                                                                                                                                                                                                                                  full text file
                                                                                                                                                                                                                                                                  pages/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle.txt
                                                                                                                                                                                                                                                                  linked prescribing information
                                                                                                                                                                                                                                                                    nct ids
                                                                                                                                                                                                                                                                    1. NCT05243550
                                                                                                                                                                                                                                                                    quality flags
                                                                                                                                                                                                                                                                      verification status
                                                                                                                                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                      2025-06-11 · FDA approves taletrectinib for ROS1-positive non-small cell lung cancer
                                                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                                                      fda-0f7fd15d941ce1a4
                                                                                                                                                                                                                                                                      event type
                                                                                                                                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                                                                                                                                      event date
                                                                                                                                                                                                                                                                      2025-06-11
                                                                                                                                                                                                                                                                      title
                                                                                                                                                                                                                                                                      FDA approves taletrectinib for ROS1-positive non-small cell lung cancer
                                                                                                                                                                                                                                                                      drug or regimen
                                                                                                                                                                                                                                                                      taletrectinib
                                                                                                                                                                                                                                                                      approval date
                                                                                                                                                                                                                                                                      2025-06-11
                                                                                                                                                                                                                                                                      approval type
                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                      approval type evidence
                                                                                                                                                                                                                                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                      indication summary
                                                                                                                                                                                                                                                                      FDA approved taletrectinib, a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer .
                                                                                                                                                                                                                                                                      indication source text
                                                                                                                                                                                                                                                                      On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
                                                                                                                                                                                                                                                                      opening context blocks
                                                                                                                                                                                                                                                                      1. On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
                                                                                                                                                                                                                                                                      tumor type mapping hints
                                                                                                                                                                                                                                                                      1. lung
                                                                                                                                                                                                                                                                      mapping status
                                                                                                                                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                      regulatory meaning
                                                                                                                                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer
                                                                                                                                                                                                                                                                      evidence source url
                                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer
                                                                                                                                                                                                                                                                      source basis
                                                                                                                                                                                                                                                                      individual FDA notification page
                                                                                                                                                                                                                                                                      source locator
                                                                                                                                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                      index date
                                                                                                                                                                                                                                                                      2025-06-11
                                                                                                                                                                                                                                                                      index description
                                                                                                                                                                                                                                                                      On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
                                                                                                                                                                                                                                                                      provenance
                                                                                                                                                                                                                                                                      retrieved at
                                                                                                                                                                                                                                                                      2026-09-09T23:22:20.222429+00:00
                                                                                                                                                                                                                                                                      local html
                                                                                                                                                                                                                                                                      pages/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer.html
                                                                                                                                                                                                                                                                      sha256
                                                                                                                                                                                                                                                                      ad7a671b07a45f07f1311e871659ba674dcececcfb8e6973eae1869716554891
                                                                                                                                                                                                                                                                      headers file
                                                                                                                                                                                                                                                                      pages/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer.headers.txt
                                                                                                                                                                                                                                                                      full text file
                                                                                                                                                                                                                                                                      pages/fda-approves-taletrectinib-ros1-positive-non-small-cell-lung-cancer.txt
                                                                                                                                                                                                                                                                      linked prescribing information
                                                                                                                                                                                                                                                                        nct ids
                                                                                                                                                                                                                                                                        1. NCT04395677
                                                                                                                                                                                                                                                                        2. NCT04919811
                                                                                                                                                                                                                                                                        quality flags
                                                                                                                                                                                                                                                                          verification status
                                                                                                                                                                                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                          2025-06-03 · FDA approves darolutamide for metastatic castration-sensitive prostate cancer
                                                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                                                          fda-6a8e7d45487d2138
                                                                                                                                                                                                                                                                          event type
                                                                                                                                                                                                                                                                          fda_oncology_approval_notification
                                                                                                                                                                                                                                                                          event date
                                                                                                                                                                                                                                                                          2025-06-03
                                                                                                                                                                                                                                                                          title
                                                                                                                                                                                                                                                                          FDA approves darolutamide for metastatic castration-sensitive prostate cancer
                                                                                                                                                                                                                                                                          drug or regimen
                                                                                                                                                                                                                                                                          darolutamide
                                                                                                                                                                                                                                                                          approval date
                                                                                                                                                                                                                                                                          2025-06-03
                                                                                                                                                                                                                                                                          approval type
                                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                                          approval type evidence
                                                                                                                                                                                                                                                                          FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                          indication summary
                                                                                                                                                                                                                                                                          FDA approved darolutamide for metastatic castration-sensitive prostate cancer . The FDA previously approved darolutamide in combination with docetaxel for mCSPC.
                                                                                                                                                                                                                                                                          indication source text
                                                                                                                                                                                                                                                                          On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.
                                                                                                                                                                                                                                                                          opening context blocks
                                                                                                                                                                                                                                                                          1. On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.
                                                                                                                                                                                                                                                                          tumor type mapping hints
                                                                                                                                                                                                                                                                          1. prostate
                                                                                                                                                                                                                                                                          mapping status
                                                                                                                                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                          regulatory meaning
                                                                                                                                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer
                                                                                                                                                                                                                                                                          evidence source url
                                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer
                                                                                                                                                                                                                                                                          source basis
                                                                                                                                                                                                                                                                          individual FDA notification page
                                                                                                                                                                                                                                                                          source locator
                                                                                                                                                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                          index date
                                                                                                                                                                                                                                                                          2025-06-03
                                                                                                                                                                                                                                                                          index description
                                                                                                                                                                                                                                                                          On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.
                                                                                                                                                                                                                                                                          provenance
                                                                                                                                                                                                                                                                          retrieved at
                                                                                                                                                                                                                                                                          2026-09-09T23:22:21.179331+00:00
                                                                                                                                                                                                                                                                          local html
                                                                                                                                                                                                                                                                          pages/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer.html
                                                                                                                                                                                                                                                                          sha256
                                                                                                                                                                                                                                                                          21d44e2470cf77cbce781fc60c7a4eccc4e56d30b0ee1db607d7de87225dcfaf
                                                                                                                                                                                                                                                                          headers file
                                                                                                                                                                                                                                                                          pages/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer.headers.txt
                                                                                                                                                                                                                                                                          full text file
                                                                                                                                                                                                                                                                          pages/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer.txt
                                                                                                                                                                                                                                                                          linked prescribing information
                                                                                                                                                                                                                                                                            nct ids
                                                                                                                                                                                                                                                                            1. NCT02799602
                                                                                                                                                                                                                                                                            quality flags
                                                                                                                                                                                                                                                                              verification status
                                                                                                                                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                              2025-05-15 · FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal
                                                                                                                                                                                                                                                                              id
                                                                                                                                                                                                                                                                              fda-8dc0436208642c00
                                                                                                                                                                                                                                                                              event type
                                                                                                                                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                                                                                                                                              event date
                                                                                                                                                                                                                                                                              2025-05-15
                                                                                                                                                                                                                                                                              title
                                                                                                                                                                                                                                                                              FDA approves retifanlimab-dlwr with carboplatin and paclitaxel and as a single agent for squamous cell carcinoma of the anal canal
                                                                                                                                                                                                                                                                              drug or regimen
                                                                                                                                                                                                                                                                              retifanlimab-dlwr with carboplatin/paclitaxel and as monotherapy
                                                                                                                                                                                                                                                                              approval date
                                                                                                                                                                                                                                                                              2025-05-15
                                                                                                                                                                                                                                                                              approval type
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              approval type evidence
                                                                                                                                                                                                                                                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                              indication summary
                                                                                                                                                                                                                                                                              FDA approved retifanlimab-dlwr with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal . The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
                                                                                                                                                                                                                                                                              indication source text
                                                                                                                                                                                                                                                                              On May 15, 2025, the Food and Drug Administration approved retifanlimab-dlwr (Zynyz, Incyte Corporation) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
                                                                                                                                                                                                                                                                              opening context blocks
                                                                                                                                                                                                                                                                              1. On May 15, 2025, the Food and Drug Administration approved retifanlimab-dlwr (Zynyz, Incyte Corporation) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
                                                                                                                                                                                                                                                                              tumor type mapping hints
                                                                                                                                                                                                                                                                              1. anal
                                                                                                                                                                                                                                                                              mapping status
                                                                                                                                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                              regulatory meaning
                                                                                                                                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma
                                                                                                                                                                                                                                                                              evidence source url
                                                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma
                                                                                                                                                                                                                                                                              source basis
                                                                                                                                                                                                                                                                              individual FDA notification page
                                                                                                                                                                                                                                                                              source locator
                                                                                                                                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                              index date
                                                                                                                                                                                                                                                                              2025-05-15
                                                                                                                                                                                                                                                                              index description
                                                                                                                                                                                                                                                                              On May 15, 2025, the Food and Drug Administration approved retifanlimab-dlwr (Zynyz, Incyte Corporation) with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
                                                                                                                                                                                                                                                                              provenance
                                                                                                                                                                                                                                                                              retrieved at
                                                                                                                                                                                                                                                                              2026-09-09T23:22:22.410527+00:00
                                                                                                                                                                                                                                                                              local html
                                                                                                                                                                                                                                                                              pages/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma.html
                                                                                                                                                                                                                                                                              sha256
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                                                                                                                                                                                                                                                                              headers file
                                                                                                                                                                                                                                                                              pages/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma.headers.txt
                                                                                                                                                                                                                                                                              full text file
                                                                                                                                                                                                                                                                              pages/fda-approves-retifanlimab-dlwr-carboplatin-and-paclitaxel-and-single-agent-squamous-cell-carcinoma.txt
                                                                                                                                                                                                                                                                              linked prescribing information
                                                                                                                                                                                                                                                                                nct ids
                                                                                                                                                                                                                                                                                1. NCT03597295
                                                                                                                                                                                                                                                                                2. NCT04472429
                                                                                                                                                                                                                                                                                quality flags
                                                                                                                                                                                                                                                                                1. multiple_regulatory_actions_require_indication_split
                                                                                                                                                                                                                                                                                verification status
                                                                                                                                                                                                                                                                                source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                2025-05-14 · FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression
                                                                                                                                                                                                                                                                                id
                                                                                                                                                                                                                                                                                fda-2f7de233a4d4da06
                                                                                                                                                                                                                                                                                event type
                                                                                                                                                                                                                                                                                fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                event date
                                                                                                                                                                                                                                                                                2025-05-14
                                                                                                                                                                                                                                                                                title
                                                                                                                                                                                                                                                                                FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression
                                                                                                                                                                                                                                                                                drug or regimen
                                                                                                                                                                                                                                                                                telisotuzumab vedotin-tllv
                                                                                                                                                                                                                                                                                approval date
                                                                                                                                                                                                                                                                                2025-05-14
                                                                                                                                                                                                                                                                                approval type
                                                                                                                                                                                                                                                                                accelerated
                                                                                                                                                                                                                                                                                approval type evidence
                                                                                                                                                                                                                                                                                accelerated explicitly stated in title/opening
                                                                                                                                                                                                                                                                                indication summary
                                                                                                                                                                                                                                                                                FDA approved telisotuzumab vedotin-tllv, a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression [≥50% of tumor cells with strong staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
                                                                                                                                                                                                                                                                                indication source text
                                                                                                                                                                                                                                                                                On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
                                                                                                                                                                                                                                                                                opening context blocks
                                                                                                                                                                                                                                                                                1. On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
                                                                                                                                                                                                                                                                                2. FDA also approved the VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) as a companion diagnostic test to aid in detecting c-Met protein overexpression in patients with non-squamous NSCLC who may be eligible for treatment with Emrelis.
                                                                                                                                                                                                                                                                                tumor type mapping hints
                                                                                                                                                                                                                                                                                1. lung
                                                                                                                                                                                                                                                                                mapping status
                                                                                                                                                                                                                                                                                heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                regulatory meaning
                                                                                                                                                                                                                                                                                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                source url
                                                                                                                                                                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression
                                                                                                                                                                                                                                                                                evidence source url
                                                                                                                                                                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression
                                                                                                                                                                                                                                                                                source basis
                                                                                                                                                                                                                                                                                individual FDA notification page
                                                                                                                                                                                                                                                                                source locator
                                                                                                                                                                                                                                                                                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                index date
                                                                                                                                                                                                                                                                                2025-05-14
                                                                                                                                                                                                                                                                                index description
                                                                                                                                                                                                                                                                                On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
                                                                                                                                                                                                                                                                                provenance
                                                                                                                                                                                                                                                                                retrieved at
                                                                                                                                                                                                                                                                                2026-09-09T23:22:23.157339+00:00
                                                                                                                                                                                                                                                                                local html
                                                                                                                                                                                                                                                                                pages/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression.html
                                                                                                                                                                                                                                                                                sha256
                                                                                                                                                                                                                                                                                404679639a43db6cd6d7d4f7c22e9ed8a99f79d296fc72e37771b58c06939c14
                                                                                                                                                                                                                                                                                headers file
                                                                                                                                                                                                                                                                                pages/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression.headers.txt
                                                                                                                                                                                                                                                                                full text file
                                                                                                                                                                                                                                                                                pages/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression.txt
                                                                                                                                                                                                                                                                                linked prescribing information
                                                                                                                                                                                                                                                                                  nct ids
                                                                                                                                                                                                                                                                                  1. NCT03539536
                                                                                                                                                                                                                                                                                  quality flags
                                                                                                                                                                                                                                                                                    verification status
                                                                                                                                                                                                                                                                                    source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                    2025-05-14 · FDA approves belzutifan for pheochromocytoma or paraganglioma
                                                                                                                                                                                                                                                                                    id
                                                                                                                                                                                                                                                                                    fda-1b5d5b6918dc4f02
                                                                                                                                                                                                                                                                                    event type
                                                                                                                                                                                                                                                                                    fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                    event date
                                                                                                                                                                                                                                                                                    2025-05-14
                                                                                                                                                                                                                                                                                    title
                                                                                                                                                                                                                                                                                    FDA approves belzutifan for pheochromocytoma or paraganglioma
                                                                                                                                                                                                                                                                                    drug or regimen
                                                                                                                                                                                                                                                                                    belzutifan
                                                                                                                                                                                                                                                                                    approval date
                                                                                                                                                                                                                                                                                    2025-05-14
                                                                                                                                                                                                                                                                                    approval type
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    approval type evidence
                                                                                                                                                                                                                                                                                    FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                    indication summary
                                                                                                                                                                                                                                                                                    FDA approved belzutifan for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma . This represents the first FDA approval of an oral therapy for PPGL.
                                                                                                                                                                                                                                                                                    indication source text
                                                                                                                                                                                                                                                                                    On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA approval of an oral therapy for PPGL.
                                                                                                                                                                                                                                                                                    opening context blocks
                                                                                                                                                                                                                                                                                    1. On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA approval of an oral therapy for PPGL.
                                                                                                                                                                                                                                                                                    tumor type mapping hints
                                                                                                                                                                                                                                                                                    1. pheochromocytoma-paraganglioma
                                                                                                                                                                                                                                                                                    mapping status
                                                                                                                                                                                                                                                                                    heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                    regulatory meaning
                                                                                                                                                                                                                                                                                    Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                    source url
                                                                                                                                                                                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma
                                                                                                                                                                                                                                                                                    evidence source url
                                                                                                                                                                                                                                                                                    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma
                                                                                                                                                                                                                                                                                    source basis
                                                                                                                                                                                                                                                                                    individual FDA notification page
                                                                                                                                                                                                                                                                                    source locator
                                                                                                                                                                                                                                                                                    Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                    index date
                                                                                                                                                                                                                                                                                    2025-05-14
                                                                                                                                                                                                                                                                                    index description
                                                                                                                                                                                                                                                                                    On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA approval of an oral therapy for PPGL.
                                                                                                                                                                                                                                                                                    provenance
                                                                                                                                                                                                                                                                                    retrieved at
                                                                                                                                                                                                                                                                                    2026-09-09T23:22:24.115794+00:00
                                                                                                                                                                                                                                                                                    local html
                                                                                                                                                                                                                                                                                    pages/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma.html
                                                                                                                                                                                                                                                                                    sha256
                                                                                                                                                                                                                                                                                    1b180fc9663a8a4ae8efbd017aab516d13e7f63dcf50e34633ff436e60e57d0f
                                                                                                                                                                                                                                                                                    headers file
                                                                                                                                                                                                                                                                                    pages/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma.headers.txt
                                                                                                                                                                                                                                                                                    full text file
                                                                                                                                                                                                                                                                                    pages/fda-approves-belzutifan-pheochromocytoma-or-paraganglioma.txt
                                                                                                                                                                                                                                                                                    linked prescribing information
                                                                                                                                                                                                                                                                                      nct ids
                                                                                                                                                                                                                                                                                      1. NCT04924075
                                                                                                                                                                                                                                                                                      quality flags
                                                                                                                                                                                                                                                                                        verification status
                                                                                                                                                                                                                                                                                        source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                        2025-05-08 · FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer
                                                                                                                                                                                                                                                                                        id
                                                                                                                                                                                                                                                                                        fda-bb4491d3eb484f1e
                                                                                                                                                                                                                                                                                        event type
                                                                                                                                                                                                                                                                                        fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                        event date
                                                                                                                                                                                                                                                                                        2025-05-08
                                                                                                                                                                                                                                                                                        title
                                                                                                                                                                                                                                                                                        FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer
                                                                                                                                                                                                                                                                                        drug or regimen
                                                                                                                                                                                                                                                                                        the combination of avutometinib and defactinib
                                                                                                                                                                                                                                                                                        approval date
                                                                                                                                                                                                                                                                                        2025-05-08
                                                                                                                                                                                                                                                                                        approval type
                                                                                                                                                                                                                                                                                        accelerated
                                                                                                                                                                                                                                                                                        approval type evidence
                                                                                                                                                                                                                                                                                        accelerated explicitly stated in title/opening
                                                                                                                                                                                                                                                                                        indication summary
                                                                                                                                                                                                                                                                                        FDA approved the combination of avutometinib and defactinib for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.
                                                                                                                                                                                                                                                                                        indication source text
                                                                                                                                                                                                                                                                                        On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
                                                                                                                                                                                                                                                                                        opening context blocks
                                                                                                                                                                                                                                                                                        1. On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
                                                                                                                                                                                                                                                                                        tumor type mapping hints
                                                                                                                                                                                                                                                                                        1. ovarian
                                                                                                                                                                                                                                                                                        mapping status
                                                                                                                                                                                                                                                                                        heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                        regulatory meaning
                                                                                                                                                                                                                                                                                        Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low
                                                                                                                                                                                                                                                                                        evidence source url
                                                                                                                                                                                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low
                                                                                                                                                                                                                                                                                        source basis
                                                                                                                                                                                                                                                                                        individual FDA notification page
                                                                                                                                                                                                                                                                                        source locator
                                                                                                                                                                                                                                                                                        Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                        index date
                                                                                                                                                                                                                                                                                        2025-05-08
                                                                                                                                                                                                                                                                                        index description
                                                                                                                                                                                                                                                                                        On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
                                                                                                                                                                                                                                                                                        provenance
                                                                                                                                                                                                                                                                                        retrieved at
                                                                                                                                                                                                                                                                                        2026-09-09T23:22:25.250236+00:00
                                                                                                                                                                                                                                                                                        local html
                                                                                                                                                                                                                                                                                        pages/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low.html
                                                                                                                                                                                                                                                                                        sha256
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                                                                                                                                                                                                                                                                                        headers file
                                                                                                                                                                                                                                                                                        pages/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low.headers.txt
                                                                                                                                                                                                                                                                                        full text file
                                                                                                                                                                                                                                                                                        pages/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low.txt
                                                                                                                                                                                                                                                                                        linked prescribing information
                                                                                                                                                                                                                                                                                          nct ids
                                                                                                                                                                                                                                                                                          1. NCT04625270
                                                                                                                                                                                                                                                                                          quality flags
                                                                                                                                                                                                                                                                                            verification status
                                                                                                                                                                                                                                                                                            source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                            2025-04-23 · FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma
                                                                                                                                                                                                                                                                                            id
                                                                                                                                                                                                                                                                                            fda-e43d505c8aaeb35e
                                                                                                                                                                                                                                                                                            event type
                                                                                                                                                                                                                                                                                            fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                            event date
                                                                                                                                                                                                                                                                                            2025-04-23
                                                                                                                                                                                                                                                                                            title
                                                                                                                                                                                                                                                                                            FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma
                                                                                                                                                                                                                                                                                            drug or regimen
                                                                                                                                                                                                                                                                                            penpulimab-kcqx
                                                                                                                                                                                                                                                                                            approval date
                                                                                                                                                                                                                                                                                            2025-04-23
                                                                                                                                                                                                                                                                                            approval type
                                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                                            approval type evidence
                                                                                                                                                                                                                                                                                            FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                            indication summary
                                                                                                                                                                                                                                                                                            FDA approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma . FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
                                                                                                                                                                                                                                                                                            indication source text
                                                                                                                                                                                                                                                                                            On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
                                                                                                                                                                                                                                                                                            opening context blocks
                                                                                                                                                                                                                                                                                            1. On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
                                                                                                                                                                                                                                                                                            tumor type mapping hints
                                                                                                                                                                                                                                                                                            1. head-and-neck
                                                                                                                                                                                                                                                                                            mapping status
                                                                                                                                                                                                                                                                                            heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                            regulatory meaning
                                                                                                                                                                                                                                                                                            Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                            source url
                                                                                                                                                                                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma
                                                                                                                                                                                                                                                                                            evidence source url
                                                                                                                                                                                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma
                                                                                                                                                                                                                                                                                            source basis
                                                                                                                                                                                                                                                                                            individual FDA notification page
                                                                                                                                                                                                                                                                                            source locator
                                                                                                                                                                                                                                                                                            Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                            index date
                                                                                                                                                                                                                                                                                            2025-04-23
                                                                                                                                                                                                                                                                                            index description
                                                                                                                                                                                                                                                                                            On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC).
                                                                                                                                                                                                                                                                                            provenance
                                                                                                                                                                                                                                                                                            retrieved at
                                                                                                                                                                                                                                                                                            2026-09-09T23:22:26.237750+00:00
                                                                                                                                                                                                                                                                                            local html
                                                                                                                                                                                                                                                                                            pages/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma.html
                                                                                                                                                                                                                                                                                            sha256
                                                                                                                                                                                                                                                                                            eb961024981c0a3d920f77ea0e01a33b775d1e194eb36d2cc496a8a126127845
                                                                                                                                                                                                                                                                                            headers file
                                                                                                                                                                                                                                                                                            pages/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma.headers.txt
                                                                                                                                                                                                                                                                                            full text file
                                                                                                                                                                                                                                                                                            pages/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma.txt
                                                                                                                                                                                                                                                                                            linked prescribing information
                                                                                                                                                                                                                                                                                              nct ids
                                                                                                                                                                                                                                                                                              1. NCT03866967
                                                                                                                                                                                                                                                                                              2. NCT04974398
                                                                                                                                                                                                                                                                                              quality flags
                                                                                                                                                                                                                                                                                              1. multiple_regulatory_actions_require_indication_split
                                                                                                                                                                                                                                                                                              verification status
                                                                                                                                                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                              2025-04-11 · FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma
                                                                                                                                                                                                                                                                                              id
                                                                                                                                                                                                                                                                                              fda-5a12fc6862fd1c47
                                                                                                                                                                                                                                                                                              event type
                                                                                                                                                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                              event date
                                                                                                                                                                                                                                                                                              2025-04-11
                                                                                                                                                                                                                                                                                              title
                                                                                                                                                                                                                                                                                              FDA approves nivolumab with ipilimumab for unresectable or metastatic hepatocellular carcinoma
                                                                                                                                                                                                                                                                                              drug or regimen
                                                                                                                                                                                                                                                                                              nivolumab with ipilimumab
                                                                                                                                                                                                                                                                                              approval date
                                                                                                                                                                                                                                                                                              2025-04-11
                                                                                                                                                                                                                                                                                              approval type
                                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                                              approval type evidence
                                                                                                                                                                                                                                                                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                              indication summary
                                                                                                                                                                                                                                                                                              FDA approved nivolumab with ipilimumab for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma .
                                                                                                                                                                                                                                                                                              indication source text
                                                                                                                                                                                                                                                                                              On April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
                                                                                                                                                                                                                                                                                              opening context blocks
                                                                                                                                                                                                                                                                                              1. On April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
                                                                                                                                                                                                                                                                                              tumor type mapping hints
                                                                                                                                                                                                                                                                                              1. liver
                                                                                                                                                                                                                                                                                              mapping status
                                                                                                                                                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                              regulatory meaning
                                                                                                                                                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma
                                                                                                                                                                                                                                                                                              evidence source url
                                                                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma
                                                                                                                                                                                                                                                                                              source basis
                                                                                                                                                                                                                                                                                              individual FDA notification page
                                                                                                                                                                                                                                                                                              source locator
                                                                                                                                                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                              index date
                                                                                                                                                                                                                                                                                              2025-04-11
                                                                                                                                                                                                                                                                                              index description
                                                                                                                                                                                                                                                                                              On April 11, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
                                                                                                                                                                                                                                                                                              provenance
                                                                                                                                                                                                                                                                                              retrieved at
                                                                                                                                                                                                                                                                                              2026-09-09T23:22:27.609873+00:00
                                                                                                                                                                                                                                                                                              local html
                                                                                                                                                                                                                                                                                              pages/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma.html
                                                                                                                                                                                                                                                                                              sha256
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                                                                                                                                                                                                                                                                                              headers file
                                                                                                                                                                                                                                                                                              pages/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma.headers.txt
                                                                                                                                                                                                                                                                                              full text file
                                                                                                                                                                                                                                                                                              pages/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-hepatocellular-carcinoma.txt
                                                                                                                                                                                                                                                                                              linked prescribing information
                                                                                                                                                                                                                                                                                                nct ids
                                                                                                                                                                                                                                                                                                1. NCT04039607
                                                                                                                                                                                                                                                                                                quality flags
                                                                                                                                                                                                                                                                                                  verification status
                                                                                                                                                                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                  2025-04-08 · FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
                                                                                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                                                                                  fda-b3dfa41ec820a8c2
                                                                                                                                                                                                                                                                                                  event type
                                                                                                                                                                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                  event date
                                                                                                                                                                                                                                                                                                  2025-04-08
                                                                                                                                                                                                                                                                                                  title
                                                                                                                                                                                                                                                                                                  FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
                                                                                                                                                                                                                                                                                                  drug or regimen
                                                                                                                                                                                                                                                                                                  nivolumab with ipilimumab
                                                                                                                                                                                                                                                                                                  approval date
                                                                                                                                                                                                                                                                                                  2025-04-08
                                                                                                                                                                                                                                                                                                  approval type
                                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                                  approval type evidence
                                                                                                                                                                                                                                                                                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                  indication summary
                                                                                                                                                                                                                                                                                                  FDA approved nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer . The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.
                                                                                                                                                                                                                                                                                                  indication source text
                                                                                                                                                                                                                                                                                                  On April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.
                                                                                                                                                                                                                                                                                                  opening context blocks
                                                                                                                                                                                                                                                                                                  1. On April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.
                                                                                                                                                                                                                                                                                                  tumor type mapping hints
                                                                                                                                                                                                                                                                                                  1. colorectal
                                                                                                                                                                                                                                                                                                  mapping status
                                                                                                                                                                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                  regulatory meaning
                                                                                                                                                                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer
                                                                                                                                                                                                                                                                                                  evidence source url
                                                                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer
                                                                                                                                                                                                                                                                                                  source basis
                                                                                                                                                                                                                                                                                                  individual FDA notification page
                                                                                                                                                                                                                                                                                                  source locator
                                                                                                                                                                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                  index date
                                                                                                                                                                                                                                                                                                  2025-04-08
                                                                                                                                                                                                                                                                                                  index description
                                                                                                                                                                                                                                                                                                  On April 8, 2025, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.
                                                                                                                                                                                                                                                                                                  provenance
                                                                                                                                                                                                                                                                                                  retrieved at
                                                                                                                                                                                                                                                                                                  2026-09-09T23:22:28.334985+00:00
                                                                                                                                                                                                                                                                                                  local html
                                                                                                                                                                                                                                                                                                  pages/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer.html
                                                                                                                                                                                                                                                                                                  sha256
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                                                                                                                                                                                                                                                                                                  headers file
                                                                                                                                                                                                                                                                                                  pages/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer.headers.txt
                                                                                                                                                                                                                                                                                                  full text file
                                                                                                                                                                                                                                                                                                  pages/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer.txt
                                                                                                                                                                                                                                                                                                  linked prescribing information
                                                                                                                                                                                                                                                                                                    nct ids
                                                                                                                                                                                                                                                                                                    1. NCT04008030
                                                                                                                                                                                                                                                                                                    quality flags
                                                                                                                                                                                                                                                                                                      verification status
                                                                                                                                                                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                      2025-03-28 · FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication
                                                                                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                                                                                      fda-f48b23d099252406
                                                                                                                                                                                                                                                                                                      event type
                                                                                                                                                                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                      event date
                                                                                                                                                                                                                                                                                                      2025-03-28
                                                                                                                                                                                                                                                                                                      title
                                                                                                                                                                                                                                                                                                      FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication
                                                                                                                                                                                                                                                                                                      drug or regimen
                                                                                                                                                                                                                                                                                                      lutetium Lu 177 vipivotide tetraxetan
                                                                                                                                                                                                                                                                                                      approval date
                                                                                                                                                                                                                                                                                                      2025-03-28
                                                                                                                                                                                                                                                                                                      approval type
                                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                                      approval type evidence
                                                                                                                                                                                                                                                                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                      indication summary
                                                                                                                                                                                                                                                                                                      FDA approved lutetium Lu 177 vipivotide tetraxetan to include adults with prostate-specific membrane antigen -positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy.
                                                                                                                                                                                                                                                                                                      indication source text
                                                                                                                                                                                                                                                                                                      On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
                                                                                                                                                                                                                                                                                                      opening context blocks
                                                                                                                                                                                                                                                                                                      1. On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
                                                                                                                                                                                                                                                                                                      2. Patients with previously treated mCRPC should be selected for Pluvicto using Locametz (active ingredient gallium Ga 68 gozetotide) or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.
                                                                                                                                                                                                                                                                                                      tumor type mapping hints
                                                                                                                                                                                                                                                                                                      1. prostate
                                                                                                                                                                                                                                                                                                      mapping status
                                                                                                                                                                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                      regulatory meaning
                                                                                                                                                                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
                                                                                                                                                                                                                                                                                                      evidence source url
                                                                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
                                                                                                                                                                                                                                                                                                      source basis
                                                                                                                                                                                                                                                                                                      individual FDA notification page
                                                                                                                                                                                                                                                                                                      source locator
                                                                                                                                                                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                      index date
                                                                                                                                                                                                                                                                                                      2025-03-28
                                                                                                                                                                                                                                                                                                      index description
                                                                                                                                                                                                                                                                                                      On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
                                                                                                                                                                                                                                                                                                      provenance
                                                                                                                                                                                                                                                                                                      retrieved at
                                                                                                                                                                                                                                                                                                      2026-09-09T23:22:30.305272+00:00
                                                                                                                                                                                                                                                                                                      local html
                                                                                                                                                                                                                                                                                                      pages/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication.html
                                                                                                                                                                                                                                                                                                      sha256
                                                                                                                                                                                                                                                                                                      6b5a42d8895a1d638cddca697860918a9d8838ae453ba08abcda6bb7fab5edb4
                                                                                                                                                                                                                                                                                                      headers file
                                                                                                                                                                                                                                                                                                      pages/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication.headers.txt
                                                                                                                                                                                                                                                                                                      full text file
                                                                                                                                                                                                                                                                                                      pages/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication.txt
                                                                                                                                                                                                                                                                                                      linked prescribing information
                                                                                                                                                                                                                                                                                                        nct ids
                                                                                                                                                                                                                                                                                                        1. NCT04689828
                                                                                                                                                                                                                                                                                                        quality flags
                                                                                                                                                                                                                                                                                                          verification status
                                                                                                                                                                                                                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                          2025-03-28 · FDA approves durvalumab for muscle invasive bladder cancer
                                                                                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                                                                                          fda-cdab6bdb583859b8
                                                                                                                                                                                                                                                                                                          event type
                                                                                                                                                                                                                                                                                                          fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                          event date
                                                                                                                                                                                                                                                                                                          2025-03-28
                                                                                                                                                                                                                                                                                                          title
                                                                                                                                                                                                                                                                                                          FDA approves durvalumab for muscle invasive bladder cancer
                                                                                                                                                                                                                                                                                                          drug or regimen
                                                                                                                                                                                                                                                                                                          durvalumab
                                                                                                                                                                                                                                                                                                          approval date
                                                                                                                                                                                                                                                                                                          2025-03-28
                                                                                                                                                                                                                                                                                                          approval type
                                                                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                                                                          approval type evidence
                                                                                                                                                                                                                                                                                                          FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                          indication summary
                                                                                                                                                                                                                                                                                                          FDA approved durvalumab with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer .
                                                                                                                                                                                                                                                                                                          indication source text
                                                                                                                                                                                                                                                                                                          On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).
                                                                                                                                                                                                                                                                                                          opening context blocks
                                                                                                                                                                                                                                                                                                          1. On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).
                                                                                                                                                                                                                                                                                                          tumor type mapping hints
                                                                                                                                                                                                                                                                                                          1. bladder
                                                                                                                                                                                                                                                                                                          mapping status
                                                                                                                                                                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                          regulatory meaning
                                                                                                                                                                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer
                                                                                                                                                                                                                                                                                                          evidence source url
                                                                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer
                                                                                                                                                                                                                                                                                                          source basis
                                                                                                                                                                                                                                                                                                          individual FDA notification page
                                                                                                                                                                                                                                                                                                          source locator
                                                                                                                                                                                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                          index date
                                                                                                                                                                                                                                                                                                          2025-03-28
                                                                                                                                                                                                                                                                                                          index description
                                                                                                                                                                                                                                                                                                          On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).
                                                                                                                                                                                                                                                                                                          provenance
                                                                                                                                                                                                                                                                                                          retrieved at
                                                                                                                                                                                                                                                                                                          2026-09-09T23:22:30.341375+00:00
                                                                                                                                                                                                                                                                                                          local html
                                                                                                                                                                                                                                                                                                          pages/fda-approves-durvalumab-muscle-invasive-bladder-cancer.html
                                                                                                                                                                                                                                                                                                          sha256
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                                                                                                                                                                                                                                                                                                          headers file
                                                                                                                                                                                                                                                                                                          pages/fda-approves-durvalumab-muscle-invasive-bladder-cancer.headers.txt
                                                                                                                                                                                                                                                                                                          full text file
                                                                                                                                                                                                                                                                                                          pages/fda-approves-durvalumab-muscle-invasive-bladder-cancer.txt
                                                                                                                                                                                                                                                                                                          linked prescribing information
                                                                                                                                                                                                                                                                                                            nct ids
                                                                                                                                                                                                                                                                                                            1. NCT03732677
                                                                                                                                                                                                                                                                                                            quality flags
                                                                                                                                                                                                                                                                                                              verification status
                                                                                                                                                                                                                                                                                                              source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                              2025-03-26 · FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET
                                                                                                                                                                                                                                                                                                              id
                                                                                                                                                                                                                                                                                                              fda-9cc973464c58ebe6
                                                                                                                                                                                                                                                                                                              event type
                                                                                                                                                                                                                                                                                                              fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                              event date
                                                                                                                                                                                                                                                                                                              2025-03-26
                                                                                                                                                                                                                                                                                                              title
                                                                                                                                                                                                                                                                                                              FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET
                                                                                                                                                                                                                                                                                                              drug or regimen
                                                                                                                                                                                                                                                                                                              cabozantinib
                                                                                                                                                                                                                                                                                                              approval date
                                                                                                                                                                                                                                                                                                              2025-03-26
                                                                                                                                                                                                                                                                                                              approval type
                                                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                                                              approval type evidence
                                                                                                                                                                                                                                                                                                              FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                              indication summary
                                                                                                                                                                                                                                                                                                              FDA approved cabozantinib for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors .
                                                                                                                                                                                                                                                                                                              indication source text
                                                                                                                                                                                                                                                                                                              On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
                                                                                                                                                                                                                                                                                                              opening context blocks
                                                                                                                                                                                                                                                                                                              1. On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
                                                                                                                                                                                                                                                                                                              tumor type mapping hints
                                                                                                                                                                                                                                                                                                              1. pancreatic
                                                                                                                                                                                                                                                                                                              2. neuroendocrine
                                                                                                                                                                                                                                                                                                              mapping status
                                                                                                                                                                                                                                                                                                              heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                              regulatory meaning
                                                                                                                                                                                                                                                                                                              Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet
                                                                                                                                                                                                                                                                                                              evidence source url
                                                                                                                                                                                                                                                                                                              https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet
                                                                                                                                                                                                                                                                                                              source basis
                                                                                                                                                                                                                                                                                                              individual FDA notification page
                                                                                                                                                                                                                                                                                                              source locator
                                                                                                                                                                                                                                                                                                              Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                              index date
                                                                                                                                                                                                                                                                                                              2025-03-26
                                                                                                                                                                                                                                                                                                              index description
                                                                                                                                                                                                                                                                                                              On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
                                                                                                                                                                                                                                                                                                              provenance
                                                                                                                                                                                                                                                                                                              retrieved at
                                                                                                                                                                                                                                                                                                              2026-09-09T23:22:31.347128+00:00
                                                                                                                                                                                                                                                                                                              local html
                                                                                                                                                                                                                                                                                                              pages/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet.html
                                                                                                                                                                                                                                                                                                              sha256
                                                                                                                                                                                                                                                                                                              f78cac08a79526aa0600012bf72d127c1af2ec9cf96b3959b0b8e0b5a7cca77b
                                                                                                                                                                                                                                                                                                              headers file
                                                                                                                                                                                                                                                                                                              pages/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet.headers.txt
                                                                                                                                                                                                                                                                                                              full text file
                                                                                                                                                                                                                                                                                                              pages/fda-approves-cabozantinib-adults-and-pediatric-patients-12-years-age-and-older-pnet-and-epnet.txt
                                                                                                                                                                                                                                                                                                              linked prescribing information
                                                                                                                                                                                                                                                                                                                nct ids
                                                                                                                                                                                                                                                                                                                1. NCT03375320
                                                                                                                                                                                                                                                                                                                quality flags
                                                                                                                                                                                                                                                                                                                  verification status
                                                                                                                                                                                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                  2025-03-19 · FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
                                                                                                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                                                                                                  fda-695234945b5fc3e9
                                                                                                                                                                                                                                                                                                                  event type
                                                                                                                                                                                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                  event date
                                                                                                                                                                                                                                                                                                                  2025-03-19
                                                                                                                                                                                                                                                                                                                  title
                                                                                                                                                                                                                                                                                                                  FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
                                                                                                                                                                                                                                                                                                                  drug or regimen
                                                                                                                                                                                                                                                                                                                  pembrolizumab
                                                                                                                                                                                                                                                                                                                  approval date
                                                                                                                                                                                                                                                                                                                  2025-03-19
                                                                                                                                                                                                                                                                                                                  approval type
                                                                                                                                                                                                                                                                                                                  traditional
                                                                                                                                                                                                                                                                                                                  approval type evidence
                                                                                                                                                                                                                                                                                                                  traditional explicitly stated in title/opening
                                                                                                                                                                                                                                                                                                                  indication summary
                                                                                                                                                                                                                                                                                                                  FDA approved pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 .
                                                                                                                                                                                                                                                                                                                  indication source text
                                                                                                                                                                                                                                                                                                                  On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
                                                                                                                                                                                                                                                                                                                  opening context blocks
                                                                                                                                                                                                                                                                                                                  1. On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
                                                                                                                                                                                                                                                                                                                  2. Pembrolizumab previously received accelerated approval for this indication on May 5, 2021, based on interim analysis of the trial described below.
                                                                                                                                                                                                                                                                                                                  tumor type mapping hints
                                                                                                                                                                                                                                                                                                                  1. gastric
                                                                                                                                                                                                                                                                                                                  mapping status
                                                                                                                                                                                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                  regulatory meaning
                                                                                                                                                                                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma
                                                                                                                                                                                                                                                                                                                  evidence source url
                                                                                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma
                                                                                                                                                                                                                                                                                                                  source basis
                                                                                                                                                                                                                                                                                                                  individual FDA notification page
                                                                                                                                                                                                                                                                                                                  source locator
                                                                                                                                                                                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                  index date
                                                                                                                                                                                                                                                                                                                  2025-03-19
                                                                                                                                                                                                                                                                                                                  index description
                                                                                                                                                                                                                                                                                                                  On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
                                                                                                                                                                                                                                                                                                                  provenance
                                                                                                                                                                                                                                                                                                                  retrieved at
                                                                                                                                                                                                                                                                                                                  2026-09-09T23:22:32.279806+00:00
                                                                                                                                                                                                                                                                                                                  local html
                                                                                                                                                                                                                                                                                                                  pages/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma.html
                                                                                                                                                                                                                                                                                                                  sha256
                                                                                                                                                                                                                                                                                                                  ad86bcb3a10301eadadf2244c1a5cace80a9e9fb38b1ac8c10953aa32339e1fd
                                                                                                                                                                                                                                                                                                                  headers file
                                                                                                                                                                                                                                                                                                                  pages/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma.headers.txt
                                                                                                                                                                                                                                                                                                                  full text file
                                                                                                                                                                                                                                                                                                                  pages/fda-approves-pembrolizumab-her2-positive-gastric-or-gastroesophageal-junction-adenocarcinoma.txt
                                                                                                                                                                                                                                                                                                                  linked prescribing information
                                                                                                                                                                                                                                                                                                                    nct ids
                                                                                                                                                                                                                                                                                                                    1. NCT03615326
                                                                                                                                                                                                                                                                                                                    quality flags
                                                                                                                                                                                                                                                                                                                      verification status
                                                                                                                                                                                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                      2025-02-14 · FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor
                                                                                                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                                                                                                      fda-969b151e3e3b8fb3
                                                                                                                                                                                                                                                                                                                      event type
                                                                                                                                                                                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                      event date
                                                                                                                                                                                                                                                                                                                      2025-02-14
                                                                                                                                                                                                                                                                                                                      title
                                                                                                                                                                                                                                                                                                                      FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor
                                                                                                                                                                                                                                                                                                                      drug or regimen
                                                                                                                                                                                                                                                                                                                      vimseltinib
                                                                                                                                                                                                                                                                                                                      approval date
                                                                                                                                                                                                                                                                                                                      2025-02-14
                                                                                                                                                                                                                                                                                                                      approval type
                                                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                                                      approval type evidence
                                                                                                                                                                                                                                                                                                                      FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                                      indication summary
                                                                                                                                                                                                                                                                                                                      FDA approved vimseltinib, a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
                                                                                                                                                                                                                                                                                                                      indication source text
                                                                                                                                                                                                                                                                                                                      On February 14, 2025, the Food and Drug Administration approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
                                                                                                                                                                                                                                                                                                                      opening context blocks
                                                                                                                                                                                                                                                                                                                      1. On February 14, 2025, the Food and Drug Administration approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
                                                                                                                                                                                                                                                                                                                      tumor type mapping hints
                                                                                                                                                                                                                                                                                                                      1. tenosynovial-giant-cell-tumor
                                                                                                                                                                                                                                                                                                                      mapping status
                                                                                                                                                                                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                      regulatory meaning
                                                                                                                                                                                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor
                                                                                                                                                                                                                                                                                                                      evidence source url
                                                                                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor
                                                                                                                                                                                                                                                                                                                      source basis
                                                                                                                                                                                                                                                                                                                      individual FDA notification page
                                                                                                                                                                                                                                                                                                                      source locator
                                                                                                                                                                                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                      index date
                                                                                                                                                                                                                                                                                                                      2025-02-14
                                                                                                                                                                                                                                                                                                                      index description
                                                                                                                                                                                                                                                                                                                      On February 14, 2025, the Food and Drug Administration approved vimseltinib (Romvimza, Deciphera Pharmaceuticals, LLC), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
                                                                                                                                                                                                                                                                                                                      provenance
                                                                                                                                                                                                                                                                                                                      retrieved at
                                                                                                                                                                                                                                                                                                                      2026-09-09T23:22:33.299862+00:00
                                                                                                                                                                                                                                                                                                                      local html
                                                                                                                                                                                                                                                                                                                      pages/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor.html
                                                                                                                                                                                                                                                                                                                      sha256
                                                                                                                                                                                                                                                                                                                      8cb3ff2d94bd7825ec297790259cbc236489a72baea5114e6476228c41cfcfed
                                                                                                                                                                                                                                                                                                                      headers file
                                                                                                                                                                                                                                                                                                                      pages/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor.headers.txt
                                                                                                                                                                                                                                                                                                                      full text file
                                                                                                                                                                                                                                                                                                                      pages/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor.txt
                                                                                                                                                                                                                                                                                                                      linked prescribing information
                                                                                                                                                                                                                                                                                                                        nct ids
                                                                                                                                                                                                                                                                                                                        1. NCT05059262
                                                                                                                                                                                                                                                                                                                        quality flags
                                                                                                                                                                                                                                                                                                                        1. may_be_supportive_care_or_nonmalignant_condition
                                                                                                                                                                                                                                                                                                                        verification status
                                                                                                                                                                                                                                                                                                                        source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                        2025-02-11 · FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
                                                                                                                                                                                                                                                                                                                        id
                                                                                                                                                                                                                                                                                                                        fda-7cfc622364fa169f
                                                                                                                                                                                                                                                                                                                        event type
                                                                                                                                                                                                                                                                                                                        fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                        event date
                                                                                                                                                                                                                                                                                                                        2025-02-11
                                                                                                                                                                                                                                                                                                                        title
                                                                                                                                                                                                                                                                                                                        FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
                                                                                                                                                                                                                                                                                                                        drug or regimen
                                                                                                                                                                                                                                                                                                                        brentuximab vedotin with lenalidomide and rituximab
                                                                                                                                                                                                                                                                                                                        approval date
                                                                                                                                                                                                                                                                                                                        2025-02-11
                                                                                                                                                                                                                                                                                                                        approval type
                                                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                                                        approval type evidence
                                                                                                                                                                                                                                                                                                                        FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                                        indication summary
                                                                                                                                                                                                                                                                                                                        FDA approved brentuximab vedotin in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma, after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation or CAR T-cell therapy.
                                                                                                                                                                                                                                                                                                                        indication source text
                                                                                                                                                                                                                                                                                                                        On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
                                                                                                                                                                                                                                                                                                                        opening context blocks
                                                                                                                                                                                                                                                                                                                        1. On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
                                                                                                                                                                                                                                                                                                                        tumor type mapping hints
                                                                                                                                                                                                                                                                                                                        1. lymphoma
                                                                                                                                                                                                                                                                                                                        mapping status
                                                                                                                                                                                                                                                                                                                        heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                        regulatory meaning
                                                                                                                                                                                                                                                                                                                        Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell
                                                                                                                                                                                                                                                                                                                        evidence source url
                                                                                                                                                                                                                                                                                                                        https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell
                                                                                                                                                                                                                                                                                                                        source basis
                                                                                                                                                                                                                                                                                                                        individual FDA notification page
                                                                                                                                                                                                                                                                                                                        source locator
                                                                                                                                                                                                                                                                                                                        Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                        index date
                                                                                                                                                                                                                                                                                                                        2025-02-12
                                                                                                                                                                                                                                                                                                                        index description
                                                                                                                                                                                                                                                                                                                        On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
                                                                                                                                                                                                                                                                                                                        provenance
                                                                                                                                                                                                                                                                                                                        retrieved at
                                                                                                                                                                                                                                                                                                                        2026-09-09T23:22:34.318923+00:00
                                                                                                                                                                                                                                                                                                                        local html
                                                                                                                                                                                                                                                                                                                        pages/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell.html
                                                                                                                                                                                                                                                                                                                        sha256
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                                                                                                                                                                                                                                                                                                                        headers file
                                                                                                                                                                                                                                                                                                                        pages/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell.headers.txt
                                                                                                                                                                                                                                                                                                                        full text file
                                                                                                                                                                                                                                                                                                                        pages/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell.txt
                                                                                                                                                                                                                                                                                                                        linked prescribing information
                                                                                                                                                                                                                                                                                                                          nct ids
                                                                                                                                                                                                                                                                                                                          1. NCT04404283
                                                                                                                                                                                                                                                                                                                          quality flags
                                                                                                                                                                                                                                                                                                                          1. index_date_differs_from_approval_date
                                                                                                                                                                                                                                                                                                                          verification status
                                                                                                                                                                                                                                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                          2025-02-11 · FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
                                                                                                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                                                                                                          fda-1737eb0935b01c53
                                                                                                                                                                                                                                                                                                                          event type
                                                                                                                                                                                                                                                                                                                          fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                          event date
                                                                                                                                                                                                                                                                                                                          2025-02-11
                                                                                                                                                                                                                                                                                                                          title
                                                                                                                                                                                                                                                                                                                          FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
                                                                                                                                                                                                                                                                                                                          drug or regimen
                                                                                                                                                                                                                                                                                                                          mirdametinib
                                                                                                                                                                                                                                                                                                                          approval date
                                                                                                                                                                                                                                                                                                                          2025-02-11
                                                                                                                                                                                                                                                                                                                          approval type
                                                                                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                                                                                          approval type evidence
                                                                                                                                                                                                                                                                                                                          FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                                          indication summary
                                                                                                                                                                                                                                                                                                                          FDA approved mirdametinib, a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.
                                                                                                                                                                                                                                                                                                                          indication source text
                                                                                                                                                                                                                                                                                                                          On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
                                                                                                                                                                                                                                                                                                                          opening context blocks
                                                                                                                                                                                                                                                                                                                          1. On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
                                                                                                                                                                                                                                                                                                                          tumor type mapping hints
                                                                                                                                                                                                                                                                                                                          1. neurofibromatosis
                                                                                                                                                                                                                                                                                                                          mapping status
                                                                                                                                                                                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                          regulatory meaning
                                                                                                                                                                                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic
                                                                                                                                                                                                                                                                                                                          evidence source url
                                                                                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic
                                                                                                                                                                                                                                                                                                                          source basis
                                                                                                                                                                                                                                                                                                                          individual FDA notification page
                                                                                                                                                                                                                                                                                                                          source locator
                                                                                                                                                                                                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                          index date
                                                                                                                                                                                                                                                                                                                          2025-02-11
                                                                                                                                                                                                                                                                                                                          index description
                                                                                                                                                                                                                                                                                                                          On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
                                                                                                                                                                                                                                                                                                                          provenance
                                                                                                                                                                                                                                                                                                                          retrieved at
                                                                                                                                                                                                                                                                                                                          2026-09-09T23:22:35.382681+00:00
                                                                                                                                                                                                                                                                                                                          local html
                                                                                                                                                                                                                                                                                                                          pages/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic.html
                                                                                                                                                                                                                                                                                                                          sha256
                                                                                                                                                                                                                                                                                                                          8d70fd8198a6779de332a3a1ded8d9f0d84cef168a57f2dfd63935c1b0aa6627
                                                                                                                                                                                                                                                                                                                          headers file
                                                                                                                                                                                                                                                                                                                          pages/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic.headers.txt
                                                                                                                                                                                                                                                                                                                          full text file
                                                                                                                                                                                                                                                                                                                          pages/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic.txt
                                                                                                                                                                                                                                                                                                                          linked prescribing information
                                                                                                                                                                                                                                                                                                                            nct ids
                                                                                                                                                                                                                                                                                                                            1. NCT03962543
                                                                                                                                                                                                                                                                                                                            quality flags
                                                                                                                                                                                                                                                                                                                            1. may_be_supportive_care_or_nonmalignant_condition
                                                                                                                                                                                                                                                                                                                            verification status
                                                                                                                                                                                                                                                                                                                            source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                            2025-01-27 · FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer
                                                                                                                                                                                                                                                                                                                            id
                                                                                                                                                                                                                                                                                                                            fda-6c8690a10014b840
                                                                                                                                                                                                                                                                                                                            event type
                                                                                                                                                                                                                                                                                                                            fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                            event date
                                                                                                                                                                                                                                                                                                                            2025-01-27
                                                                                                                                                                                                                                                                                                                            title
                                                                                                                                                                                                                                                                                                                            FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer
                                                                                                                                                                                                                                                                                                                            drug or regimen
                                                                                                                                                                                                                                                                                                                            fam-trastuzumab deruxtecan-nxki
                                                                                                                                                                                                                                                                                                                            approval date
                                                                                                                                                                                                                                                                                                                            2025-01-27
                                                                                                                                                                                                                                                                                                                            approval type
                                                                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                                                                            approval type evidence
                                                                                                                                                                                                                                                                                                                            FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                                            indication summary
                                                                                                                                                                                                                                                                                                                            FDA approved fam-trastuzumab deruxtecan-nxki for unresectable or metastatic hormone receptor -positive, HER2-low or HER2-ultralow breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
                                                                                                                                                                                                                                                                                                                            indication source text
                                                                                                                                                                                                                                                                                                                            On January 27, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
                                                                                                                                                                                                                                                                                                                            opening context blocks
                                                                                                                                                                                                                                                                                                                            1. On January 27, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
                                                                                                                                                                                                                                                                                                                            2. FDA also approved the Ventana’s PATHWAY anti-HER-2 (4B5) Rabbit Monoclonal Primary Antibody assay as a companion diagnostic device to identify patients with HER2-ultralow (IHC 0 with membrane staining) breast cancer for treatment with Enhertu. This assay was previously approved to identify patients with HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer for treatment with Enhertu.
                                                                                                                                                                                                                                                                                                                            tumor type mapping hints
                                                                                                                                                                                                                                                                                                                            1. breast
                                                                                                                                                                                                                                                                                                                            mapping status
                                                                                                                                                                                                                                                                                                                            heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                            regulatory meaning
                                                                                                                                                                                                                                                                                                                            Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                            source url
                                                                                                                                                                                                                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2
                                                                                                                                                                                                                                                                                                                            evidence source url
                                                                                                                                                                                                                                                                                                                            https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2
                                                                                                                                                                                                                                                                                                                            source basis
                                                                                                                                                                                                                                                                                                                            individual FDA notification page
                                                                                                                                                                                                                                                                                                                            source locator
                                                                                                                                                                                                                                                                                                                            Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                            index date
                                                                                                                                                                                                                                                                                                                            2025-01-27
                                                                                                                                                                                                                                                                                                                            index description
                                                                                                                                                                                                                                                                                                                            On January 27, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
                                                                                                                                                                                                                                                                                                                            provenance
                                                                                                                                                                                                                                                                                                                            retrieved at
                                                                                                                                                                                                                                                                                                                            2026-09-09T23:22:37.224973+00:00
                                                                                                                                                                                                                                                                                                                            local html
                                                                                                                                                                                                                                                                                                                            pages/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2.html
                                                                                                                                                                                                                                                                                                                            sha256
                                                                                                                                                                                                                                                                                                                            c86881349813dcae0ba077aa6c79bb921d1409b8d056b593d988bfd6172ca1d2
                                                                                                                                                                                                                                                                                                                            headers file
                                                                                                                                                                                                                                                                                                                            pages/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2.headers.txt
                                                                                                                                                                                                                                                                                                                            full text file
                                                                                                                                                                                                                                                                                                                            pages/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2.txt
                                                                                                                                                                                                                                                                                                                            linked prescribing information
                                                                                                                                                                                                                                                                                                                              nct ids
                                                                                                                                                                                                                                                                                                                              1. NCT04494425
                                                                                                                                                                                                                                                                                                                              quality flags
                                                                                                                                                                                                                                                                                                                                verification status
                                                                                                                                                                                                                                                                                                                                source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                                2025-01-21 · FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS
                                                                                                                                                                                                                                                                                                                                id
                                                                                                                                                                                                                                                                                                                                fda-eed3ef224dcd705a
                                                                                                                                                                                                                                                                                                                                event type
                                                                                                                                                                                                                                                                                                                                fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                                event date
                                                                                                                                                                                                                                                                                                                                2025-01-21
                                                                                                                                                                                                                                                                                                                                title
                                                                                                                                                                                                                                                                                                                                FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS
                                                                                                                                                                                                                                                                                                                                drug or regimen
                                                                                                                                                                                                                                                                                                                                treosulfan with fludarabine
                                                                                                                                                                                                                                                                                                                                approval date
                                                                                                                                                                                                                                                                                                                                2025-01-21
                                                                                                                                                                                                                                                                                                                                approval type
                                                                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                                                                approval type evidence
                                                                                                                                                                                                                                                                                                                                FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                                                indication summary
                                                                                                                                                                                                                                                                                                                                FDA approved treosulfan, an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia or myelodysplastic syndrome .
                                                                                                                                                                                                                                                                                                                                indication source text
                                                                                                                                                                                                                                                                                                                                On January 21, 2025, the Food and Drug Administration approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
                                                                                                                                                                                                                                                                                                                                opening context blocks
                                                                                                                                                                                                                                                                                                                                1. On January 21, 2025, the Food and Drug Administration approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
                                                                                                                                                                                                                                                                                                                                tumor type mapping hints
                                                                                                                                                                                                                                                                                                                                1. leukemia
                                                                                                                                                                                                                                                                                                                                2. myelodysplastic
                                                                                                                                                                                                                                                                                                                                mapping status
                                                                                                                                                                                                                                                                                                                                heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                                regulatory meaning
                                                                                                                                                                                                                                                                                                                                Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                                source url
                                                                                                                                                                                                                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or
                                                                                                                                                                                                                                                                                                                                evidence source url
                                                                                                                                                                                                                                                                                                                                https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or
                                                                                                                                                                                                                                                                                                                                source basis
                                                                                                                                                                                                                                                                                                                                individual FDA notification page
                                                                                                                                                                                                                                                                                                                                source locator
                                                                                                                                                                                                                                                                                                                                Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                                index date
                                                                                                                                                                                                                                                                                                                                2025-02-06
                                                                                                                                                                                                                                                                                                                                index description
                                                                                                                                                                                                                                                                                                                                On January 21, 2025, the Food and Drug Administration approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
                                                                                                                                                                                                                                                                                                                                provenance
                                                                                                                                                                                                                                                                                                                                retrieved at
                                                                                                                                                                                                                                                                                                                                2026-09-09T23:22:36.318123+00:00
                                                                                                                                                                                                                                                                                                                                local html
                                                                                                                                                                                                                                                                                                                                pages/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or.html
                                                                                                                                                                                                                                                                                                                                sha256
                                                                                                                                                                                                                                                                                                                                d3a57b4f01ad6080e52ce54ac90dfca3bcfd56590467a5c94f084faadace9f79
                                                                                                                                                                                                                                                                                                                                headers file
                                                                                                                                                                                                                                                                                                                                pages/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or.headers.txt
                                                                                                                                                                                                                                                                                                                                full text file
                                                                                                                                                                                                                                                                                                                                pages/fda-approves-treosulfan-fludarabine-preparative-regimen-allohsct-adult-and-pediatric-patients-aml-or.txt
                                                                                                                                                                                                                                                                                                                                linked prescribing information
                                                                                                                                                                                                                                                                                                                                  nct ids
                                                                                                                                                                                                                                                                                                                                  1. NCT00822393
                                                                                                                                                                                                                                                                                                                                  quality flags
                                                                                                                                                                                                                                                                                                                                  1. index_date_differs_from_approval_date
                                                                                                                                                                                                                                                                                                                                  verification status
                                                                                                                                                                                                                                                                                                                                  source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                                  2025-01-17 · FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer
                                                                                                                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                                                                                                                  fda-718ebee3ee60ca74
                                                                                                                                                                                                                                                                                                                                  event type
                                                                                                                                                                                                                                                                                                                                  fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                                  event date
                                                                                                                                                                                                                                                                                                                                  2025-01-17
                                                                                                                                                                                                                                                                                                                                  title
                                                                                                                                                                                                                                                                                                                                  FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer
                                                                                                                                                                                                                                                                                                                                  drug or regimen
                                                                                                                                                                                                                                                                                                                                  datopotamab deruxtecan-dlnk
                                                                                                                                                                                                                                                                                                                                  approval date
                                                                                                                                                                                                                                                                                                                                  2025-01-17
                                                                                                                                                                                                                                                                                                                                  approval type
                                                                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                                                                  approval type evidence
                                                                                                                                                                                                                                                                                                                                  FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                                                  indication summary
                                                                                                                                                                                                                                                                                                                                  FDA approved datopotamab deruxtecan-dlnk, a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor -positive, human epidermal growth factor receptor 2 -negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
                                                                                                                                                                                                                                                                                                                                  indication source text
                                                                                                                                                                                                                                                                                                                                  On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
                                                                                                                                                                                                                                                                                                                                  opening context blocks
                                                                                                                                                                                                                                                                                                                                  1. On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
                                                                                                                                                                                                                                                                                                                                  tumor type mapping hints
                                                                                                                                                                                                                                                                                                                                  1. breast
                                                                                                                                                                                                                                                                                                                                  mapping status
                                                                                                                                                                                                                                                                                                                                  heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                                  regulatory meaning
                                                                                                                                                                                                                                                                                                                                  Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast
                                                                                                                                                                                                                                                                                                                                  evidence source url
                                                                                                                                                                                                                                                                                                                                  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast
                                                                                                                                                                                                                                                                                                                                  source basis
                                                                                                                                                                                                                                                                                                                                  individual FDA notification page
                                                                                                                                                                                                                                                                                                                                  source locator
                                                                                                                                                                                                                                                                                                                                  Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                                  index date
                                                                                                                                                                                                                                                                                                                                  2025-01-17
                                                                                                                                                                                                                                                                                                                                  index description
                                                                                                                                                                                                                                                                                                                                  On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
                                                                                                                                                                                                                                                                                                                                  provenance
                                                                                                                                                                                                                                                                                                                                  retrieved at
                                                                                                                                                                                                                                                                                                                                  2026-09-09T23:22:39.202611+00:00
                                                                                                                                                                                                                                                                                                                                  local html
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                                                                                                                                                                                                                                                                                                                                  pages/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast.txt
                                                                                                                                                                                                                                                                                                                                  linked prescribing information
                                                                                                                                                                                                                                                                                                                                    nct ids
                                                                                                                                                                                                                                                                                                                                    1. NCT05104866
                                                                                                                                                                                                                                                                                                                                    quality flags
                                                                                                                                                                                                                                                                                                                                      verification status
                                                                                                                                                                                                                                                                                                                                      source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                                      2025-01-16 · FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma
                                                                                                                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                                                                                                                      fda-7fa68eece0cf7e41
                                                                                                                                                                                                                                                                                                                                      event type
                                                                                                                                                                                                                                                                                                                                      fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                                      event date
                                                                                                                                                                                                                                                                                                                                      2025-01-16
                                                                                                                                                                                                                                                                                                                                      title
                                                                                                                                                                                                                                                                                                                                      FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma
                                                                                                                                                                                                                                                                                                                                      drug or regimen
                                                                                                                                                                                                                                                                                                                                      acalabrutinib with bendamustine and rituximab
                                                                                                                                                                                                                                                                                                                                      approval date
                                                                                                                                                                                                                                                                                                                                      2025-01-16
                                                                                                                                                                                                                                                                                                                                      approval type
                                                                                                                                                                                                                                                                                                                                      traditional
                                                                                                                                                                                                                                                                                                                                      approval type evidence
                                                                                                                                                                                                                                                                                                                                      traditional explicitly stated in title/opening
                                                                                                                                                                                                                                                                                                                                      indication summary
                                                                                                                                                                                                                                                                                                                                      FDA approved acalabrutinib with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation .
                                                                                                                                                                                                                                                                                                                                      indication source text
                                                                                                                                                                                                                                                                                                                                      On January 16, 2025, the Food and Drug Administration granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
                                                                                                                                                                                                                                                                                                                                      opening context blocks
                                                                                                                                                                                                                                                                                                                                      1. On January 16, 2025, the Food and Drug Administration granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
                                                                                                                                                                                                                                                                                                                                      2. FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Acalabrutinib received accelerated approval for this indication in 2017.
                                                                                                                                                                                                                                                                                                                                      tumor type mapping hints
                                                                                                                                                                                                                                                                                                                                      1. lymphoma
                                                                                                                                                                                                                                                                                                                                      mapping status
                                                                                                                                                                                                                                                                                                                                      heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                                      regulatory meaning
                                                                                                                                                                                                                                                                                                                                      Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma
                                                                                                                                                                                                                                                                                                                                      evidence source url
                                                                                                                                                                                                                                                                                                                                      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma
                                                                                                                                                                                                                                                                                                                                      source basis
                                                                                                                                                                                                                                                                                                                                      individual FDA notification page
                                                                                                                                                                                                                                                                                                                                      source locator
                                                                                                                                                                                                                                                                                                                                      Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                                      index date
                                                                                                                                                                                                                                                                                                                                      2025-01-16
                                                                                                                                                                                                                                                                                                                                      index description
                                                                                                                                                                                                                                                                                                                                      On January 16, 2025, the Food and Drug Administration granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
                                                                                                                                                                                                                                                                                                                                      provenance
                                                                                                                                                                                                                                                                                                                                      retrieved at
                                                                                                                                                                                                                                                                                                                                      2026-09-09T23:22:41.317928+00:00
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                                                                                                                                                                                                                                                                                                                                      sha256
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                                                                                                                                                                                                                                                                                                                                      pages/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma.headers.txt
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                                                                                                                                                                                                                                                                                                                                      pages/fda-approves-acalabrutinib-bendamustine-and-rituximab-previously-untreated-mantle-cell-lymphoma.txt
                                                                                                                                                                                                                                                                                                                                      linked prescribing information
                                                                                                                                                                                                                                                                                                                                        nct ids
                                                                                                                                                                                                                                                                                                                                        1. NCT02972840
                                                                                                                                                                                                                                                                                                                                        quality flags
                                                                                                                                                                                                                                                                                                                                          verification status
                                                                                                                                                                                                                                                                                                                                          source_extracted_not_clinically_reviewed
                                                                                                                                                                                                                                                                                                                                          2025-01-16 · FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer
                                                                                                                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                                                                                                                          fda-616257e683ecd313
                                                                                                                                                                                                                                                                                                                                          event type
                                                                                                                                                                                                                                                                                                                                          fda_oncology_approval_notification
                                                                                                                                                                                                                                                                                                                                          event date
                                                                                                                                                                                                                                                                                                                                          2025-01-16
                                                                                                                                                                                                                                                                                                                                          title
                                                                                                                                                                                                                                                                                                                                          FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer
                                                                                                                                                                                                                                                                                                                                          drug or regimen
                                                                                                                                                                                                                                                                                                                                          sotorasib with panitumumab
                                                                                                                                                                                                                                                                                                                                          approval date
                                                                                                                                                                                                                                                                                                                                          2025-01-16
                                                                                                                                                                                                                                                                                                                                          approval type
                                                                                                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                                                                                                          approval type evidence
                                                                                                                                                                                                                                                                                                                                          FDA says approved; pathway not explicitly stated in title/opening, so not inferred
                                                                                                                                                                                                                                                                                                                                          indication summary
                                                                                                                                                                                                                                                                                                                                          FDA approved sotorasib with panitumumab for adult patients with KRAS G12C-mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
                                                                                                                                                                                                                                                                                                                                          indication source text
                                                                                                                                                                                                                                                                                                                                          On January 16, 2025, the Food and Drug Administration approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
                                                                                                                                                                                                                                                                                                                                          opening context blocks
                                                                                                                                                                                                                                                                                                                                          1. On January 16, 2025, the Food and Drug Administration approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
                                                                                                                                                                                                                                                                                                                                          2. Today, the FDA also approved the therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device to aid in identifying patients with colorectal cancer whose tumors harbor KRAS G12C mutations and who may be eligible for Lumakras with Vectibix.
                                                                                                                                                                                                                                                                                                                                          tumor type mapping hints
                                                                                                                                                                                                                                                                                                                                          1. colorectal
                                                                                                                                                                                                                                                                                                                                          mapping status
                                                                                                                                                                                                                                                                                                                                          heuristic_requires_editorial_review
                                                                                                                                                                                                                                                                                                                                          regulatory meaning
                                                                                                                                                                                                                                                                                                                                          Dated US FDA approval notification for the stated use; not a guideline recommendation, treatment ranking, proof of survival benefit, or confirmation the indication remains current. Reconcile current label, subsequent changes and withdrawal status.
                                                                                                                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer
                                                                                                                                                                                                                                                                                                                                          evidence source url
                                                                                                                                                                                                                                                                                                                                          https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer
                                                                                                                                                                                                                                                                                                                                          source basis
                                                                                                                                                                                                                                                                                                                                          individual FDA notification page
                                                                                                                                                                                                                                                                                                                                          source locator
                                                                                                                                                                                                                                                                                                                                          Page title and opening approval paragraph; exact text and additional introductory blocks preserved
                                                                                                                                                                                                                                                                                                                                          index date
                                                                                                                                                                                                                                                                                                                                          2025-01-16
                                                                                                                                                                                                                                                                                                                                          index description
                                                                                                                                                                                                                                                                                                                                          On January 16, 2025, the Food and Drug Administration approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
                                                                                                                                                                                                                                                                                                                                          provenance
                                                                                                                                                                                                                                                                                                                                          retrieved at
                                                                                                                                                                                                                                                                                                                                          2026-09-09T23:22:40.331250+00:00
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                                                                                                                                                                                                                                                                                                                                          pages/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer.html
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                                                                                                                                                                                                                                                                                                                                          pages/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer.headers.txt
                                                                                                                                                                                                                                                                                                                                          full text file
                                                                                                                                                                                                                                                                                                                                          pages/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer.txt
                                                                                                                                                                                                                                                                                                                                          linked prescribing information
                                                                                                                                                                                                                                                                                                                                            nct ids
                                                                                                                                                                                                                                                                                                                                            1. NCT05198934
                                                                                                                                                                                                                                                                                                                                            quality flags
                                                                                                                                                                                                                                                                                                                                              verification status
                                                                                                                                                                                                                                                                                                                                              source_extracted_not_clinically_reviewed

                                                                                                                                                                                                                                                                                                                                              Preserved source evidence · Independent clinical review pending · Not medical advice