Tecentriq FDA Approval History
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, Breast 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), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), heptatocellular carcinoma and melanoma.
Tecentriq Indications
Urothelial Carcinoma
- Tecentriq is indicated 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, or
- have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.
Non-Small Cell Lung Cancer (NSCLC)
- Tecentriq is indicated 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.
- Tecentriq is indicated 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.
- Tecentriq is indicated 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.
- Tecentriq 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.
Triple-Negative Breast Cancer (TNBC)
- Tecentriq is indicated in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA approved test. This indication is approved under accelerated approval based on progression free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Small Cell Lung Cancer (SCLC)
- Tecentriq is indicated in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Heptatocellular Carcinoma (HCC)
- Tecentriq is indicated in combination with bevacizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.
Melanoma
- Tecentriq is indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Development Timeline for Tecentriq
Further information
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