U.S. License Holder:
Genentech Inc.
Date of License:
September-12-2024
Last Update:
Nov-15-2024
FDA-Approved Indications
TECENTRIQ HYBREZA (atezolizumab and hyaluronidase-tqjs) is a combination of atezolizumab, a programmed death-ligand 1 (PD-L1) blocking antibody, and hyaluronidase, an endoglycosidase indicated:
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 greater than or equal to 1 percent 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 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 Hybreza;
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 adult patients with unresectable or metastatic HCC who have not received prior systemic therapy;
Melanoma: In combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as determined by an FDA-approved test;
Alveolar Soft Part Sarcoma (ASPS): For the treatment of adult patients with unresectable or metastatic ASPS.