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

Further information

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