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Tecentriq FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 8, 2021.

FDA Approved: Yes (First approved May 18, 2016)
Brand name: Tecentriq
Generic name: atezolizumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Bladder Cancer, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma, Melanoma, Metastatic

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), heptatocellular carcinoma and melanoma.

  • Tecentriq is indicated for:
    • Urothelial Carcinoma
      • for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:
        • are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor infiltrating immune cells [IC] covering ≥ 5% of the tumor area), as determined by an FDA-approved test, or
        • are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
          This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    • 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-approved test.
      • 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-approved test, with no EGFR or ALK genomic tumor aberrations.
      • in combination with bevacizumab, paclitaxel, and carboplatin, for the firstline treatment of adult patients with metastatic non squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
      • in combination with paclitaxel protein-bound and carboplatin for the firstline treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
      • 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.
    • 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).
    • Hepatocellular Carcinoma (HCC)
      • in combination with bevacizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.
    • Melanoma
      • in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
  • Tecentriq is administered via intravenous infusion over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Development Timeline for Tecentriq

DateArticle
Oct 15, 2021Approval  FDA Approves Genentech’s Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Cancer
Aug 27, 2021Genentech Provides Update on Tecentriq U.S. Indication for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
Mar  7, 2021Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer
Jul 30, 2020Approval  FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma
May 29, 2020Approval  FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With Hepatocellular Carcinoma
May 18, 2020Approval  FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
Dec  3, 2019Approval  FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Mar 18, 2019Approval  FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
Mar  8, 2019Approval  FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
Dec  6, 2018Approval  FDA Approves Genentech’s Tecentriq in Combination With Avastin and Chemotherapy for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Apr 17, 2017Approval  FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer
Oct 18, 2016Approval  FDA Approves Genentech’s Cancer Immunotherapy Tecentriq (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer
May 18, 2016Approval  FDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma

See Also

Tecentriq (atezolizumab) Consumer Information

Further information

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