U.S. License Holder:
Genentech Inc.
Date of License:
May-18-2016
Last Update:
June-30-2020
FDA-Approved Indications
TECENTRIQ (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in:
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 greater than or equal to 5 percent 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) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD_L1 expression (PD-L1 stained greater than or equal to 50 percent of tumor cells [TC greater than or equal to 50 percent] or PD-L1 stained tumor-infiltrating immune cells [IC] covering greater than or equal to 10 percent of the tumor area [IC greater than or equal to 10 percent]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; In combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment, of patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; 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; 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): 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 greater than or equal to 1 percent of the tumor area), as determined by an FDA approved test;
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.
U.S. Patent Litigations