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Tecentriq FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 19, 2022.

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

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

  • Tecentriq is indicated for:
    • 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.
    • Alveolar Soft Part Sarcoma (ASPS)
      • for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS.
  • Tecentriq is administered via intravenous infusion over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
  • Warnings and precautions associated with Tecentriq include immune-mediated adverse reactions which may be severe or fatal, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.
  • Common adverse reactions when used as a single agent include fatigue/asthenia, decreased appetite, nausea, cough, and dyspnea.
    Common adverse reactions in NSCLC and SCLC patients when used in combination with other antineoplastic drugs include fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and decreased appetite.
    Common adverse reactions in HCC patients when used in combination with bevacizumab include hypertension, fatigue and proteinuria.
    Common adverse reactions in melanoma patients when used in combination with cobimetinib and vemurafenib include rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reactions.

Development timeline for Tecentriq

DateArticle
Jun 28, 2023Genprex Receives Fast Track Designation for REQORSA Immunogene Therapy in Combination with Tecentriq for the Treatment of Small Cell Lung Cancer
Dec  9, 2022Approval FDA Approves Genentech’s Tecentriq as First-Ever Therapy for a Certain Advanced Rare Sarcoma Called Alveolar Soft Part Sarcoma (ASPS)
Nov 28, 2022Genentech Provides Update on Tecentriq U.S. Indication for Previously Untreated Metastatic Bladder Cancer
Aug  2, 2022Positive Results Announced from Phase III IMscin001 Study Evaluating Subcutaneous Formulation of Tecentriq with ENHANZE in Advanced Non-Small Cell Lung Cancer
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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