Tecentriq Hybreza FDA Approval History
FDA Approved: Yes (First approved September 12, 2024)
Brand name: Tecentriq Hybreza
Generic name: atezolizumab and hyaluronidase-tqjs
Dosage form: Injection
Company: Genentech, Inc.
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) is a programmed death-ligand 1 (PD-L1) blocking antibody and endoglycosidase combination used for the treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.
- Tecentriq Hybreza is a subcutaneous formulation that reduces administration time to approximately 7 minutes, compared with 30-60 minutes for Tecentriq intravenous infusion.
- Tecentriq Hybreza is intended to provide greater flexibility of treatment options while showing safety and efficacy consistent with Tecentriq intravenous infusion.
- Tecentriq Hybreza is indicated for:
- 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 ≥ 1% 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 ≥ 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 FDAapproved test, with no EGFR or ALK genomic tumor aberrations.
• 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.
• in combination with paclitaxel protein-bound and carboplatin for the firstline 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.
Development timeline for Tecentriq Hybreza
| Date | Article |
|---|---|
| Sep 12, 2024 | Approval FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy |
Further information
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