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.

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)

• 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

Date	Article
Jul 30, 2020	ApprovalFDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma
May 29, 2020	ApprovalFDA Approves Genentech’s Tecentriq in Combination With Avastin for People With Hepatocellular Carcinoma
May 18, 2020	ApprovalFDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
Dec  3, 2019	ApprovalFDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Mar 18, 2019	ApprovalFDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
Mar  8, 2019	ApprovalFDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
Dec  6, 2018	ApprovalFDA 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, 2017	ApprovalFDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer
Oct 18, 2016	ApprovalFDA Approves Genentech’s Cancer Immunotherapy Tecentriq (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer
May 18, 2016	ApprovalFDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma

Further information

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