GENENTECH — Avastin FDA Review (NDA/BLA 125085, 2021)
Roche Holding AG · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Genentech's Avastin (bevacizumab), approved June 20, 2019, for multiple metastatic cancers including colorectal, lung, glioblastoma, renal cell, cervical, and ovarian/fallopian tube/peritoneal cancers. It outlines dosage, administration, and critical warnings. Safety data highlights adverse reactions like wound healing complications, hemorrhage, thromboembolic events, hypertension, and embryo-fetal toxicity, with incidence rates provided for various indications. Efficacy studies demonstrate improved overall and progression-free survival in several settings, though not in adjuvant colon cancer. A 2019 sBLA proposed removing the Boxed Warning and updating safety information, with the FDA providing comments on labeling revisions.
Key findings — cited to the page
| incidence of Grades 2-4 proteinuria with Avastin + chemotherapy | 5 % | · p.18 |
| second episode of Grades 2-4 proteinuria after reinitiating Avastin | 48 % | · p.18 |
| overall incidence of proteinuria (all grades) in Study BO17705 | 20 % | BO17705 · p.18 |
| incidence of Grades 3-4 VTE (Study GOG-0240) with chemotherapy alone | 5 % | GOG-0240 · p.17 |
| resolution of Grades 2-4 proteinuria | 74 % | · p.18 |
| reinitiation of Avastin after Grades 2-4 proteinuria | 42 % | · p.18 |
| incidence of Grades 3-5 ATE with Avastin + chemotherapy | 5 % | · p.17 |
| incidence of Grades 3-4 VTE (Study EORTC 26101) with Avastin + chemotherapy | 5 % | EORTC 26101 · p.17 |
| incidence of Grades 3-5 ATE with chemotherapy alone | 2 % | · p.17 |
| incidence of Grades 3-4 VTE (Study GOG-0240) with Avastin + chemotherapy | 11 % | GOG-0240 · p.17 |
| incidence of Grades 3-4 VTE (Study EORTC 26101) with chemotherapy alone | 2 % | EORTC 26101 · p.17 |
| incidence of Grade > 3 left ventricular dysfunction with Avastin | 1 % | · p.19 |
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 →