Treats metastatic NSCLC. BLA 761347, held by Genentech Inc. Atezolizumab And Hyaluronidase-Tqjs.
As of Nov 13, 2026, BLA 761347 (Tecentriq Hybreza), held by Genentech Inc, was first approved by FDA on Sep 12, 2024, with 7 approved supplements and 0 published complete response letters.
TECENTRIQ HYBREZA 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 ≥ 1% of tumor cells, as determined by an FDA-authorized test.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2026 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| May 15, 2026 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 24, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Oct 2, 2025 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Sep 12, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tecentriq Hybreza125MG;2000UNITS PER ML · injectable;injection | Atezolizumab And Hyaluronidase-Tqjs | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 2026 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| May 15, 2026 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| May 12, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Nov 24, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Nov 17, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Oct 2, 2025 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Aug 18, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Sep 12, 2024 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
