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LABELS · 4b922b35-c401-4189-a8b2-9f9a820878db

TECENTRIQ

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-05-20
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. ( 1.1 , 14.1 ) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations ( 1.1 ) for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. ( 1.1 ) Small Cell Lung Cancer (SCLC) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). ( 1.2 ) in combination with lurbinectedin, for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. ( 1.2 ) Hepatocellular Carcinoma (HCC) in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy. ( 1.3 ) Melanoma in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. ( 1.4 ) Alveolar Soft Part Sarcoma (ASPS) for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS. ( 1.5 ) Muscle Invasive Bladder Cancer (MIBC) as adjuvant treatment of adult patients with MIBC after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test. ( 1.6 ) 1.1 Non-Small Cell Lung Cancer TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA [see Clinical Studies (14.1) ] non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations [see Dosage and Administration (2.1) ]. TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. 1.2 Small Cell Lung Cancer TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). TECENTRIQ, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. 1.3 Hepatocellular Carcinoma TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 1.4 Melanoma TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] . 1.5 Alveolar Soft Part Sarcoma TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). 1.6 Muscle Invasive Bladder Cancer TECENTRIQ, as a single agent, is indicated as adjuvant treatment of adult patients 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 [see Dosage and Administration (2.1) ] .
Full extracted label fields
application numbers
  1. BLA761034
boxed warning exact
    brand names
    1. TECENTRIQ
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6fa682c9-a312-4932-9831-f286908660ee
    generic names
    1. ATEZOLIZUMAB
    id
    4b922b35-c401-4189-a8b2-9f9a820878db
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. ( 1.1 , 14.1 ) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations ( 1.1 ) for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. ( 1.1 ) Small Cell Lung Cancer (SCLC) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). ( 1.2 ) in combination with lurbinectedin, for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. ( 1.2 ) Hepatocellular Carcinoma (HCC) in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy. ( 1.3 ) Melanoma in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. ( 1.4 ) Alveolar Soft Part Sarcoma (ASPS) for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS. ( 1.5 ) Muscle Invasive Bladder Cancer (MIBC) as adjuvant treatment of adult patients with MIBC after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test. ( 1.6 ) 1.1 Non-Small Cell Lung Cancer TECENTRIQ, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II to IIIA [see Clinical Studies (14.1) ] non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations [see Dosage and Administration (2.1) ]. TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. 1.2 Small Cell Lung Cancer TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). TECENTRIQ, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. 1.3 Hepatocellular Carcinoma TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 1.4 Melanoma TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] . 1.5 Alveolar Soft Part Sarcoma TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). 1.6 Muscle Invasive Bladder Cancer TECENTRIQ, as a single agent, is indicated as adjuvant treatment of adult patients 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 [see Dosage and Administration (2.1) ] .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Genentech, Inc.
      matched search terms
      1. cancer
      2. carcinoma
      3. sarcoma
      4. melanoma
      5. tumor
      6. tumors
      package ndcs
      1. 50242-917-01
      2. 50242-917-86
      3. 50242-918-01
      product ndcs
      1. 50242-917
      2. 50242-918
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1.2 ) 10/2025 Indications and Usage ( 1.6 ) 05/2026 Dosage and Administration ( 2.4 ) 03/2026 Dosage and Administration ( 2.1 , 2.2 , 2.4 ) 05/2026 Warnings and Precautions ( 5.1 ) 05/2026 Warnings and Precautions ( 5.2 ) 08/2025
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      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
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      url
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      source url
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      spl effective date
      2026-05-20
      spl effective time
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      spl set id
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      spl version
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      substance names
      1. ATEZOLIZUMAB
      uniis
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      verification flags
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      Drugs@FDA application source records
      1. application number
        BLA761034
        payload
        all indexed label documents
        1. Appl No
          761034
          Application Docs Date
          2016-05-18 00:00:00
          Application Docs ID
          40639
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761034
          Application Docs Date
          2017-04-24 00:00:00
          Application Docs ID
          48094
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          761034
          Application Docs Date
          2018-03-14 00:00:00
          Application Docs ID
          52965
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        4. Appl No
          761034
          Application Docs Date
          2018-05-03 00:00:00
          Application Docs ID
          54008
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        5. Appl No
          761034
          Application Docs Date
          2018-06-20 00:00:00
          Application Docs ID
          54614
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        6. Appl No
          761034
          Application Docs Date
          2018-06-21 00:00:00
          Application Docs ID
          54667
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        7. Appl No
          761034
          Application Docs Date
          2018-06-28 00:00:00
          Application Docs ID
          54720
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        8. Appl No
          761034
          Application Docs Date
          2018-07-02 00:00:00
          Application Docs ID
          54739
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        9. Appl No
          761034
          Application Docs Date
          2018-12-06 00:00:00
          Application Docs ID
          56640
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        10. Appl No
          761034
          Application Docs Date
          2019-03-08 00:00:00
          Application Docs ID
          57936
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        11. Appl No
          761034
          Application Docs Date
          2019-03-19 00:00:00
          Application Docs ID
          58028
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        12. Appl No
          761034
          Application Docs Date
          2019-05-07 00:00:00
          Application Docs ID
          58585
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761034
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          62
          Submission Status
          AP
          Submission Status Date
          2026-05-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          761034
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          61
          Submission Status
          AP
          Submission Status Date
          2026-05-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761034
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          59
          Submission Status
          AP
          Submission Status Date
          2025-11-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761034
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          58
          Submission Status
          AP
          Submission Status Date
          2025-10-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          761034
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          57
          Submission Status
          AP
          Submission Status Date
          2025-08-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          761034
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          53
          Submission Status
          AP
          Submission Status Date
          2024-04-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          761034
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          51
          Submission Status
          AP
          Submission Status Date
          2023-05-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          761034
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          50
          Submission Status
          AP
          Submission Status Date
          2022-12-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          761034
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          49
          Submission Status
          AP
          Submission Status Date
          2023-05-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          761034
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          47
          Submission Status
          AP
          Submission Status Date
          2022-12-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          761034
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          44
          Submission Status
          AP
          Submission Status Date
          2021-10-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          761034
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          43
          Submission Status
          AP
          Submission Status Date
          2022-01-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761034
        approval interpretation
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        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2026-05-15
        latest label selection rule
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        latest posted label documents
        1. Appl No
          761034
          Application Docs Date
          2026-05-19 00:00:00
          Application Docs ID
          85973
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          61
          Submission Type
          SUPPL
        official application record
        Appl No
        761034
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        GENENTECH INC
        openfda application present
        true
        products
        1. Active Ingredient
          ATEZOLIZUMAB
          Appl No
          761034
          Drug Name
          TECENTRIQ
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          1200MG/20ML
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. BLA761034
      brand names
      1. TECENTRIQ
      classification reasons
      1. explicit_positive_indication_predicate
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      exact text
      1 INDICATIONS AND USAGE TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. ( 1.1 , 14.1 ) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infil
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      is a programmed death-ligand 1 (PD-L1) blocking antibody indicated
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        ent following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 express
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        CATIONS AND USAGE TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following re
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                                                      4. context exact
                                                        TECENTRIQ, as a single-agent, is indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.
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                                                          ontaining chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. 1.2 Small Cell Lung Cancer TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). TECENTRIQ, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENT
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                                                            1.2 Small Cell Lung Cancer TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
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                                                            1.2 Small Cell Lung Cancer TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). TECENTRIQ, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. 1.3 Hepatocellular Carcinoma TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not r
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                                                              ntenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. 1.3 Hepatocellular Carcinoma TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 1.4 Melanoma TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dos
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                                                                ination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (H
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                                                                static hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
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                                                              5. context exact
                                                                1.3 Hepatocellular Carcinoma TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
                                                                kind
                                                                regimen
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                                                                not_inferred
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                                                                in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior system
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                                                                  NSCLC
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                                                                  Non-Small Cell Lung Cancer
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                                                                1.3 Hepatocellular Carcinoma TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
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                                                                limitations
                                                                Source null
                                                                line
                                                                Source null
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                                                                Source null
                                                                regimen
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                                                                tumor histology
                                                                Source null
                                                                use intent
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                                                                application numbers
                                                                1. BLA761034
                                                                brand names
                                                                1. TECENTRIQ
                                                                classification reasons
                                                                1. explicit_positive_indication_predicate
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                                                                CENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 1.4 Melanoma TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] . 1.5 Alveolar Soft Part Sarcoma TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part
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                                                                qualifier mentions
                                                                1. context exact
                                                                  imetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic
                                                                  kind
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                                                                  enib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] .
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                                                                  BRAF V600 mutation-positive unresectable or
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                                                                  t patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] .
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                                                                  biomarker
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                                                                  not_inferred
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                                                                  5181
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                                                                  metastatic melanoma [see Dosage and Adminis
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                                                                4. context exact
                                                                  reatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] .
                                                                  kind
                                                                  stage_or_setting
                                                                  polarity
                                                                  not_inferred
                                                                  span
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                                                                  5169
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                                                                  true
                                                                  exact text
                                                                  unresectable or metastatic melanoma [see Dosage
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                                                                5. context exact
                                                                  1.4 Melanoma TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] .
                                                                  kind
                                                                  regimen
                                                                  polarity
                                                                  not_inferred
                                                                  span
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                                                                  5170
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage
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                                                                    NSCLC
                                                                    definition exact
                                                                    Non-Small Cell Lung Cancer
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                                                                    136
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    Non-Small Cell Lung Cancer (NSCLC)
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                                                                  1.4 Melanoma TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] .
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                                                                  age
                                                                  Source null
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                                                                  Source null
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                                                                  Source null
                                                                  limitations
                                                                  Source null
                                                                  line
                                                                  Source null
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                                                                  Source null
                                                                  tumor histology
                                                                  Source null
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                                                                  application numbers
                                                                  1. BLA761034
                                                                  brand names
                                                                  1. TECENTRIQ
                                                                  classification reasons
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                                                                  nation with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Dosage and Administration (2.1) ] . 1.5 Alveolar Soft Part Sarcoma TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). 1.6 Muscle Invasive Bladder Cancer TECENTRIQ, as a single agent, is indicated as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating
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                                                                  is indicated
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                                                                  qualifier mentions
                                                                  1. context exact
                                                                    NTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unrese
                                                                    kind
                                                                    age
                                                                    polarity
                                                                    not_inferred
                                                                    span
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                                                                    5299
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                                                                    true
                                                                    exact text
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                                                                    label id
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                                                                  2. context exact
                                                                    a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic al
                                                                    kind
                                                                    age
                                                                    polarity
                                                                    not_inferred
                                                                    span
                                                                    end
                                                                    5322
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                                                                    true
                                                                    exact text
                                                                    pediatric patients
                                                                    label id
                                                                    4b922b35-c401-4189-a8b2-9f9a820878db
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                                                                  3. context exact
                                                                    indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft par
                                                                    kind
                                                                    age
                                                                    polarity
                                                                    not_inferred
                                                                    span
                                                                    end
                                                                    5337
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    2 years of age
                                                                    label id
                                                                    4b922b35-c401-4189-a8b2-9f9a820878db
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                                                                    5323
                                                                  4. context exact
                                                                    tric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).
                                                                    kind
                                                                    biomarker
                                                                    polarity
                                                                    not_inferred
                                                                    span
                                                                    end
                                                                    5412
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    metastatic alveolar soft part sarcoma (ASPS
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                                                                  5. context exact
                                                                    adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).
                                                                    kind
                                                                    stage_or_setting
                                                                    polarity
                                                                    not_inferred
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                                                                    unresectable or metastatic alveolar soft part s
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                                                                  6. context exact
                                                                    1.5 Alveolar Soft Part Sarcoma TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).
                                                                    kind
                                                                    regimen
                                                                    polarity
                                                                    not_inferred
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                                                                    exact text
                                                                    as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS)
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                                                                      Non-Small Cell Lung Cancer
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                                                                    1.5 Alveolar Soft Part Sarcoma TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).
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                                                                    spl effective date
                                                                    2026-05-20
                                                                    spl set id
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                                                                    age
                                                                    Source null
                                                                    approval pathway
                                                                    Source null
                                                                    biomarker and test
                                                                    Source null
                                                                    disease stage
                                                                    Source null
                                                                    limitations
                                                                    Source null
                                                                    line
                                                                    Source null
                                                                    prior therapy
                                                                    Source null
                                                                    regimen
                                                                    Source null
                                                                    tumor histology
                                                                    Source null
                                                                    use intent
                                                                    tumor_directed_candidate
                                                                    Passage 28 · positive indication candidate
                                                                    application numbers
                                                                    1. BLA761034
                                                                    brand names
                                                                    1. TECENTRIQ
                                                                    classification reasons
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                                                                    clinical review status
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                                                                    exact text
                                                                    t Part Sarcoma TECENTRIQ, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). 1.6 Muscle Invasive Bladder Cancer TECENTRIQ, as a single agent, is indicated as adjuvant treatment of adult patients 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 [see Dosage and Administration (2.1) ] .
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                                                                    dup-41dda1084cdf1e3e76c2
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                                                                    generic names
                                                                    1. ATEZOLIZUMAB
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                                                                    exact text
                                                                    is indicated
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                                                                    qualifier mentions
                                                                    1. context exact
                                                                      Q, as a single agent, is indicated as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC) after cystectomy
                                                                      kind
                                                                      age
                                                                      polarity
                                                                      not_inferred
                                                                      span
                                                                      end
                                                                      5532
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                                                                      adult patients
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                                                                      5518
                                                                    2. context exact
                                                                      ladder Cancer TECENTRIQ, as a single agent, is indicated as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC) after cystectomy who ha
                                                                      kind
                                                                      stage_or_setting
                                                                      polarity
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                                                                      end
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                                                                      adjuvant treatment of adult patients with m
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                                                                      5496
                                                                    3. context exact
                                                                      1.6 Muscle Invasive Bladder Cancer TECENTRIQ, as a single agent, is indicated as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized
                                                                      kind
                                                                      regimen
                                                                      polarity
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                                                                      5638
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                                                                      true
                                                                      exact text
                                                                      as a single agent, is indicated as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC) after cystectomy who have circulating tumor DNA molecular resi
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                                                                      source defined aliases
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                                                                        NSCLC
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                                                                        Non-Small Cell Lung Cancer
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                                                                        136
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                                                                        true
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                                                                        Non-Small Cell Lung Cancer (NSCLC)
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                                                                      exact text
                                                                      1.6 Muscle Invasive Bladder Cancer TECENTRIQ, as a single agent, is indicated as adjuvant treatment of adult patients 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 [see Dosage and Administration (2.1) ] .
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                                                                      source url
                                                                      https://api.fda.gov/drug/label.json?search=id%3A%224b922b35-c401-4189-a8b2-9f9a820878db%22
                                                                      spl effective date
                                                                      2026-05-20
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                                                                      age
                                                                      Source null
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                                                                      Source null
                                                                      disease stage
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                                                                      limitations
                                                                      Source null
                                                                      line
                                                                      Source null
                                                                      prior therapy
                                                                      Source null
                                                                      regimen
                                                                      Source null
                                                                      tumor histology
                                                                      Source null
                                                                      use intent
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                                                                      Preserved source evidence · Not medical advice