GENENTECH — Avastin FDA Review (NDA/BLA 125085, 2023)
Roche Holding AG · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Genentech's Avastin (bevacizumab) and its combination with Tecentriq (atezolizumab) for various cancer indications, approved May 29, 2020. Avastin is approved for metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian/fallopian tube/peritoneal cancer, and, notably, hepatocellular carcinoma (HCC) in combination with atezolizumab. Clinical trials, particularly IMbrave150, demonstrated significant efficacy for the atezolizumab/bevacizumab combination in unresectable HCC, showing improved overall survival (OS) and progression-free survival (PFS) compared to sorafenib. For instance, IMbrave150 reported a median OS not reached versus 13.2 months for sorafenib (HR 0.58), and median PFS of 6.8 months versus 4.3 months (HR 0.59). The report also outlines Avastin's efficacy across other cancers, highlighting improvements in survival and response rates when combined with chemotherapy. Safety profiles for both drugs, including adverse events and anti-drug antibody impact, were consistent with known characteristics, leading to a favorable risk-benefit assessment for the atezolizumab/bevacizumab combination in HCC. The document also provides dosage, administration guidelines, and recommendations for prescribing information.
Key findings — cited to the page
| Blood Bilirubin Increased (All Grades) | 13.1 % | IMbrave150 · p.172 |
| Aspartate Aminotransferase Increased (All Grades) | 19.5 % | IMbrave150 · p.172 |
| Alanine Aminotransferase Increased (All Grades) | 14 % | IMbrave150 · p.172 |
| Alanine Aminotransferase Increased (Grades 3-4) | 3.6 % | IMbrave150 · p.172 |
| Pyrexia (Grades 3-4) | 0 % | IMbrave150 · p.172 |
| Proteinuria (All Grades) | 20.1 % | IMbrave150 · p.172 |
| Fatigue (Grades 3-4) | 2.4 % | IMbrave150 · p.172 |
| Aspartate Aminotransferase Increased (Grades 3-4) | 7.0 % | IMbrave150 · p.172 |
| Fatigue (All Grades) | 20.4 % | IMbrave150 · p.172 |
| Proteinuria (Grades 3-4) | 3 % | IMbrave150 · p.172 |
| Pyrexia (All Grades) | 17.9 % | IMbrave150 · p.172 |
| Blood Bilirubin Increased (Grades 3-4) | 2.4 % | IMbrave150 · p.172 |
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 →