DISEASE & TREATMENT SETTING
Non-Small Cell Lung Cancer
Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.
Exact scope
Non-Small Cell Lung Cancer
- Source population
- Not part of this definition
- Disease extent
- Not part of this definition
- Treatment line
- Not part of this definition
- Stage
- Not part of this definition
- Resectability
- Not part of this definition
Biomarkers, prior therapy and derivation
- molecular
- prior therapy
- derivation status
- source-attested
- derivation note
- Derived from NCI topic(s): Non-Small Cell Lung Cancer. Strongest NCIt resolution: exact. Entity-level scope; stage, biomarker and treatment line are not yet part of this definition.
- source wording
- Source null
107 more-specific settings
Datroway: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration after prior therapy →Emrelis: metastatic Non-small cell lung cancer with MET stated without a specific alteration after prior therapy →Hernexeos: unresectable metastatic Non-small cell lung cancer with HER2 stated without a specific alteration, ERBB2 stated without a specific alteration after prior therapy →Hernexeos: unresectable metastatic Non-small cell lung cancer with HER2 stated without a specific alteration, ERBB2 stated without a specific alteration →Hyrnuo: metastatic Non-small cell lung cancer with HER2 stated without a specific alteration, ERBB2 stated without a specific alteration →Hyrnuo: metastatic Non-small cell lung cancer with HER2 stated without a specific alteration, ERBB2 stated without a specific alteration after prior therapy →Krazati: metastatic Non-small cell lung cancer with KRAS stated without a specific alteration after prior therapy →Lumakras: metastatic Non-small cell lung cancer with KRAS stated without a specific alteration after prior therapy →Zegfrovy: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration →Gavreto: metastatic Non-small cell lung cancer with RET fusion →Retevmo: metastatic Non-small cell lung cancer with RET fusion →Tepmetko: metastatic Non-small cell lung cancer with MET stated without a specific alteration →Exkivity: metastatic Non-small cell lung cancer with EGFR exon 20 insertion after prior therapy →LAZCLUZE: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line) →Docetaxel: unresectable metastatic Non-small cell lung cancer →ALECENSA: Non-small cell lung cancer with ALK Positive, ALK stated without a specific alteration (adjuvant) after prior therapy →IRESSA: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line) →BEIZRAY: unresectable metastatic Non-small cell lung cancer (adjuvant) after prior therapy →MEKTOVI: metastatic Non-small cell lung cancer with BRAF V600E →AXTLE: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →BRAFTOVI: metastatic Non-small cell lung cancer with BRAF V600E →IMFINZI: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy →Docetaxel: unresectable metastatic Non-small cell lung cancer (adjuvant) after prior therapy →PEMETREXED DIPOTASSIUM: metastatic Non-small cell lung cancer (first-line) after prior therapy →Gemcitabine: metastatic Non-small cell lung cancer (first-line) →Pemfexy: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →Tecentriq Hybreza: metastatic Non-small cell lung cancer with PD-L1 stated without a specific alteration, EGFR stated without a specific alteration, ALK stated without a specific a →TABRECTA: metastatic Non-small cell lung cancer with MET stated without a specific alteration →Avastin: unresectable metastatic Non-small cell lung cancer (first-line) →PEMETREXED: metastatic Non-small cell lung cancer →ENSACOVE: metastatic Non-small cell lung cancer with ALK stated without a specific alteration →ZYKADIA: metastatic Non-small cell lung cancer with ALK stated without a specific alteration →TECENTRIQ: Non-small cell lung cancer with PD-L1 stated without a specific alteration (adjuvant) after prior therapy →Lorbrena: metastatic Non-small cell lung cancer with ALK stated without a specific alteration →KEYTRUDA: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) →BIZENGRI: unresectable metastatic Non-small cell lung cancer after prior therapy →OPDIVO QVANTIG: resectable Non-small cell lung cancer (neoadjuvant) →Tafinlar: metastatic Non-small cell lung cancer with BRAF V600E →Pemetrexed: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →Alunbrig: metastatic Non-small cell lung cancer with ALK stated without a specific alteration →Enhertu: unresectable metastatic Non-small cell lung cancer with HER2 Mutant, HER2 stated without a specific alteration, ERBB2 stated without a specific alteration after prior ther →Gilotrif: metastatic Non-small cell lung cancer with EGFR Mutation, EGFR stated without a specific alteration (first-line) →ABRAXANE: metastatic Non-small cell lung cancer (first-line) →BEIZRAY: metastatic Non-small cell lung cancer after prior therapy →Pemetrexed: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →RETEVMO: metastatic Non-small cell lung cancer with RET stated without a specific alteration →BEIZRAY: unresectable metastatic Non-small cell lung cancer →Rybrevant: metastatic Non-small cell lung cancer with MET stated without a specific alteration, EGFR stated without a specific alteration (first-line) →Docetaxel: metastatic Non-small cell lung cancer after prior therapy →AXTLE: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →RETEVMO: metastatic Non-small cell lung cancer with RET Fusion, RET stated without a specific alteration →Vizimpro: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line) →Paclitaxel: metastatic Non-small cell lung cancer (first-line) →DOCIVYX: unresectable metastatic Non-small cell lung cancer →YERVOY: metastatic Non-small cell lung cancer with PD-L1 stated without a specific alteration, EGFR stated without a specific alteration, ALK stated without a specific alteration ( →ALYMSYS: unresectable metastatic Non-small cell lung cancer (first-line) →OPDIVO QVANTIG: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy →IBTROZI: metastatic Non-small cell lung cancer with ROS1 stated without a specific alteration →CYRAMZA: metastatic Non-small cell lung cancer after prior therapy →PEMRYDI RTU: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →Mekinist: metastatic Non-small cell lung cancer with BRAF V600E →IMJUDO: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →TECENTRIQ: Non-small cell lung cancer with PD-L1 stated without a specific alteration (adjuvant) after prior therapy →Pemfexy: metastatic Non-small cell lung cancer →Gavreto: metastatic Non-small cell lung cancer with RET Fusion, RET fusion →KEYTRUDA QLEX: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) →Alimta: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →JIDEYTRO: metastatic Non-small cell lung cancer with ROS1 stated without a specific alteration →Rozlytrek: metastatic Non-small cell lung cancer with ROS1 stated without a specific alteration →Zirabev: unresectable metastatic Non-small cell lung cancer (first-line) →Tecentriq Hybreza: Non-small cell lung cancer with PD-L1 stated without a specific alteration (adjuvant) after prior therapy →TECENTRIQ: metastatic Non-small cell lung cancer with PD-L1 stated without a specific alteration, EGFR stated without a specific alteration, ALK stated without a specific alteratio →BIZENGRI: unresectable metastatic Non-small cell lung cancer with HER2 stated without a specific alteration after prior therapy →Rybrevant: metastatic Non-small cell lung cancer with EGFR Exon 19 Deletion, EGFR stated without a specific alteration (first-line) →AVGEMSI: metastatic Non-small cell lung cancer (first-line) →ALECENSA: Non-small cell lung cancer with ALK stated without a specific alteration (adjuvant) after prior therapy →OPDIVO: resectable Non-small cell lung cancer with EGFR mutations, ALK rearrangements (neoadjuvant) after prior therapy →DOCIVYX: unresectable metastatic Non-small cell lung cancer (adjuvant) after prior therapy →OPDIVO: resectable Non-small cell lung cancer (neoadjuvant) →TAGRISSO: Non-small cell lung cancer with EGFR stated without a specific alteration (adjuvant) after prior therapy →OPDIVO QVANTIG: metastatic Non-small cell lung cancer after prior therapy →OPDIVO: resectable Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (neoadjuvant) after prior therapy →JOBEVNE: unresectable metastatic Non-small cell lung cancer (first-line) →CYRAMZA: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line) →Gavreto: metastatic Non-small cell lung cancer with RET stated without a specific alteration →MVASI: unresectable metastatic Non-small cell lung cancer (first-line) →Gilotrif: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, EGFR mutations (first-line) after prior therapy →PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND: metastatic Non-small cell lung cancer (first-line) →Alimta: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration →TAGRISSO: Non-small cell lung cancer with EGFR Mutation, EGFR stated without a specific alteration (adjuvant) after prior therapy →Vegzelma: unresectable metastatic Non-small cell lung cancer (first-line) →PEMRYDI RTU: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration, ALK stated without a specific alteration (first-line) after prior therapy →DOCIVYX: metastatic Non-small cell lung cancer after prior therapy →Augtyro: metastatic Non-small cell lung cancer with ROS1 stated without a specific alteration →Xalkori: metastatic Non-small cell lung cancer with ALK stated without a specific alteration, ROS1 Positive, ROS1 positive →Rybrevant Faspro: metastatic Non-small cell lung cancer with EGFR Exon 19 Deletion, EGFR stated without a specific alteration (first-line) →Stage 0 Non-Small Cell Lung Cancer →Stage IB Non-Small Cell Lung Cancer →Stage IIIA Non-Small Cell Lung Cancer →Stage IIIA Non-Small Cell Lung Cancer →Stage IIIA Non-Small Cell Lung Cancer →locally advanced Non-Small Cell Lung Cancer →Stage IV recurrent Non-Small Cell Lung Cancer →Stage IV recurrent Non-Small Cell Lung Cancer →Stage I Non-Small Cell Lung Cancer →Stage II Non-Small Cell Lung Cancer →Stage IIIB Non-Small Cell Lung Cancer →
Study evidence for this setting
BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)
Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma
A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)
A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer
QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
A Broad Multi-histology Phase II Study of the Multi-Kinase Inhibitor R935788 (Fostamatinib Disodium) in Advanced Colorectal, Non-small Cell Lung, Head and Neck Hepatocellular and R
An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anapla
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin
Indication-specific source history
2020-05-08 · Retevmo (selpercatinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-dd76ce3b980a0820
- event date
- 2020-05-08
- event kind
- accelerated-approval
- drug or regimen
- Retevmo (selpercatinib)
- source indication text
- Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-e3591ea14459aba9db9d
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2020-09-04 · Gavreto (pralsetinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-09ce96ddfc864901
- event date
- 2020-09-04
- event kind
- accelerated-approval
- drug or regimen
- Gavreto (pralsetinib)
- source indication text
- Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-f1bd2f76ea52efe6c081
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2021-02-03 · Tepmetko (tepotinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-c38fb46e1d42f141
- event date
- 2021-02-03
- event kind
- accelerated-approval
- drug or regimen
- Tepmetko (tepotinib)
- source indication text
- Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-c23b04eb67672e5e0497
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2021-05-28 · Lumakras (sotorasib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-9ed32ca2bb5fe831
- event date
- 2021-05-28
- event kind
- accelerated-approval
- drug or regimen
- Lumakras (sotorasib)
- source indication text
- Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-1560c86153e4a495fb2c
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2021-09-15 · Exkivity (mobocertinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-bf7a5aebbe84a1c9
- event date
- 2021-09-15
- event kind
- accelerated-approval
- drug or regimen
- Exkivity (mobocertinib)
- source indication text
- Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- withdrawn
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-21fd32ccc7ace4c77d83
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2022-09-21 · Retevmo (selpercatinib) · traditional approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-df35cefb104e0515
- event date
- 2022-09-21
- event kind
- traditional-approval
- drug or regimen
- Retevmo (selpercatinib)
- source indication text
- Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC)
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-e3591ea14459aba9db9d
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2022-12-12 · Krazati (adagrasib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-3d8647b6e644dd83
- event date
- 2022-12-12
- event kind
- accelerated-approval
- drug or regimen
- Krazati (adagrasib)
- source indication text
- Adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-07225e854ead88e41b45
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2023-08-09 · Gavreto (pralsetinib) · traditional approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-c909ea00792cf068
- event date
- 2023-08-09
- event kind
- traditional-approval
- drug or regimen
- Gavreto (pralsetinib)
- source indication text
- Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-f1bd2f76ea52efe6c081
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2024-02-15 · Tepmetko (tepotinib) · traditional approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-9385f3cdc63d9f85
- event date
- 2024-02-15
- event kind
- traditional-approval
- drug or regimen
- Tepmetko (tepotinib)
- source indication text
- Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- verified_clinical_benefit
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-c23b04eb67672e5e0497
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2024-07-15 · Exkivity (mobocertinib) · withdrawal
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-c6244566cc233929
- event date
- 2024-07-15
- event kind
- withdrawal
- drug or regimen
- Exkivity (mobocertinib)
- source indication text
- Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- withdrawn
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-21fd32ccc7ace4c77d83
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-05-14 · Emrelis (telisotuzumab vedotin-tllv) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-bc852a4da8a2bac4
- event date
- 2025-05-14
- event kind
- accelerated-approval
- drug or regimen
- Emrelis (telisotuzumab vedotin-tllv)
- source indication text
- Treatment of adult patients 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-1bdc47f45493f905a5e7
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-05-14 · telisotuzumab vedotin-tllv · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-1b123c30be3a05c2
- event date
- 2025-05-14
- event kind
- approval-notification
- drug or regimen
- telisotuzumab vedotin-tllv
- source indication text
- 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- accelerated
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-2f7de233a4d4da06
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-06-11 · taletrectinib · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-73e400125327b95e
- event date
- 2025-06-11
- event kind
- approval-notification
- drug or regimen
- taletrectinib
- source indication text
- FDA approved taletrectinib, a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer .
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- Source null
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-0f7fd15d941ce1a4
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-06-23 · Datroway (datopotamab deruxtecan-dlnk) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-db0545bbaf1a88f9
- event date
- 2025-06-23
- event kind
- accelerated-approval
- drug or regimen
- Datroway (datopotamab deruxtecan-dlnk)
- source indication text
- Treatment of adult patients 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-b29e6e916d89560e828a
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-06-23 · datopotamab deruxtecan-dlnk · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-dd180377b26bf720
- event date
- 2025-06-23
- event kind
- approval-notification
- drug or regimen
- datopotamab deruxtecan-dlnk
- source indication text
- 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- accelerated
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-29743855ffd67cd9
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-07-02 · Zegfrovy (sunvozertinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-1b628574904396b6
- event date
- 2025-07-02
- event kind
- accelerated-approval
- drug or regimen
- Zegfrovy (sunvozertinib)
- source indication text
- Treatment of 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
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-079ab36594871b1f41b2
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-07-02 · sunvozertinib · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-c8cbb85cbd2d4981
- event date
- 2025-07-02
- event kind
- approval-notification
- drug or regimen
- sunvozertinib
- source indication text
- 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- accelerated
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-29a56844a8ee9ae3
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-08-08 · Hernexeos (zongertinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-1270b9a947c2ad5f
- event date
- 2025-08-08
- event kind
- accelerated-approval
- drug or regimen
- Hernexeos (zongertinib)
- source indication text
- Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA approved test, and who have received prior systemic therapy
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-54553a738243b9da33e1
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-08-08 · zongertinib · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-f2609f5cb5cb39a1
- event date
- 2025-08-08
- event kind
- approval-notification
- drug or regimen
- zongertinib
- source indication text
- 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- accelerated
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-7d091a8440ce03e5
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-11-19 · Hyrnuo (sevabertinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-2bbdc85ad026f270
- event date
- 2025-11-19
- event kind
- accelerated-approval
- drug or regimen
- Hyrnuo (sevabertinib)
- source indication text
- Treatment of 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-approved test, and who have received a prior systemic therapy
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-daaf01f51985f0cf8178
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2025-11-19 · sevabertinib · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-56aa7fde42009a56
- event date
- 2025-11-19
- event kind
- approval-notification
- drug or regimen
- sevabertinib
- source indication text
- 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- accelerated
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-26f47f4afac6d968
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-02-26 · Hernexeos (zongertinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-e6c39cb199f7bd4f
- event date
- 2026-02-26
- event kind
- accelerated-approval
- drug or regimen
- Hernexeos (zongertinib)
- source indication text
- Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-acf999b5dcbb789c416e
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-02-26 · zongertinib · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-25bc57241bb0ca37
- event date
- 2026-02-26
- event kind
- approval-notification
- drug or regimen
- zongertinib
- source indication text
- 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- accelerated
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-3a7f03155778019c
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-07-22 · zidesamtinib · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-210d96cd68e9f2ad
- event date
- 2026-07-22
- event kind
- approval-notification
- drug or regimen
- zidesamtinib
- source indication text
- 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 .
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- Source null
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-e0f74c6ff06b5fd4
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-09-09 · Hyrnuo (sevabertinib) · accelerated approval
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- fda-1008e60858d8505e
- event date
- 2026-09-09
- event kind
- accelerated-approval
- drug or regimen
- Hyrnuo (sevabertinib)
- source indication text
- Treatment of 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
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- ongoing
- has date discrepancy
- 0
- source collection
- fda-status-row
- source key
- fda-aa-1fbc5cf6f5df6b5af351
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
2026-09-09 · sevabertinib · approval notification
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- event id
- notice-01b9eada22c2ee5e
- event date
- 2026-09-09
- event kind
- approval-notification
- drug or regimen
- sevabertinib
- source indication text
- 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.
- match phrase
- non-small cell lung cancer
- match status
- candidate
- status category
- accelerated
- has date discrepancy
- 0
- source collection
- fda-approval-notice
- source key
- fda-31fccf3ff6d99d7d
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Source relationships and population-mapping limitations
- bindings
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-small-cell-lung-cancer
- binding id
- ncit-C2926
- source collection
- ncit-concept
- source key
- C2926
- source excerpt
- Source null
- match status
- exact
- match note
- Source null
- recorded at
- 2026-09-10T00:00:00Z
- mappings
Download this complete draft source relationship record →
Preserved source evidence · Not medical advice
Triangle