GENENTECH — Avastin FDA Review (NDA/BLA 125085, 2022)
Roche Holding AG · 2022 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package for Genentech's Avastin (bevacizumab), dated December 5, 2017, details its approved indications for various metastatic cancers, including colorectal, non-small cell lung, glioblastoma, renal cell, cervical, and ovarian cancers. The report highlights Avastin's efficacy in improving progression-free survival across these indications, often in combination with chemotherapy, though a consistent overall survival benefit was not always observed, particularly in glioblastoma. The safety profile of Avastin is extensively reviewed, noting common and severe adverse reactions such as venous thromboembolic events, hypertension, proteinuria, and bleeding. Updates to warnings, especially regarding congestive heart failure, are included. The report also covers the regulatory history for glioblastoma, including accelerated approval and subsequent studies (EORTC 26101, AVAglio, RTOG 0825) that supported full approval based on improved progression-free survival and corticosteroid-sparing effects, despite no significant overall survival benefit.
Key findings — cited to the page
| second episode of Grade 2-4 proteinuria | 48 % | · p.18 |
| Grade > 3 left ventricular dysfunction | 1 % | · p.19 |
| Grades 2-4 proteinuria | 5 % | · p.17 |
| Grade 3-4 hypertension | 5 % | · p.17 |
| Grades 2-4 proteinuria resolved | 74 % | · p.18 |
| Grade 3-4 hypertension | 18 % | · p.17 |
| overall incidence of proteinuria (all grades) | 20 % | Study BO17705 · p.17 |
| Grade 3-4 proteinuria | 0.7 % | · p.17 |
| Grade 3-4 VTE | 5 % | EORTC 26101 · p.17 |
| Grade 3-4 VTE | 11 % | Study GOG-0240 · p.17 |
| Grade 3-4 proteinuria | 7 % | · p.17 |
| Neutropenia (Grade 2-4) | 31 % | Study MO22224 · p.20 |
Source: Roche Holding AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →