U.S. License Holder:
Genentech Inc.
Date of License:
September-12-2024
Last Update:
October-08-2026
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);
In combination with lurbinectedin, for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with TECENTRIQ HYBREZA or intravenous atezolizumab, and carboplatin plus etoposide;
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 and pediatric patients (12 years of age and older who weigh 40 kg or greater) with unresectable or metastatic ASPS;
Muscle Invasive Bladder Cancer (MIBC): As adjuvant treatment of adult patients with MIBC after cystectomy who have circulating tumor DNA molecular residual disease (ctDNA MRD) as determined by an FDA-authorized test;
Mismatch Repair-Deficient Colon Cancer: In combination with a fluoropyrimidine and oxaliplatin, is indicated for the adjuvant treatment of adult patients and pediatric patients (12 years of age and older who weigh 40 kg or greater) with Stage III, mismatch repair deficient (dMMR) colon cancer.