GENENTECH — Herceptin FDA Review (NDA/BLA 103792, 2017)
Roche Holding AG · 2017 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Genentech's supplemental Biologics License Application for Herceptin (trastuzumab) on April 27, 2017. This approval primarily updated labeling, including HIGHLIGHTS, DOSAGE AND ADMINISTRATION for consistent infusion times and therapy duration, and companion diagnostic information. The report details Herceptin's efficacy in HER2-positive metastatic breast and gastric cancers, presenting disease-free and overall survival data from multiple adjuvant breast cancer trials. Safety concerns include cardiac dysfunction, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity. The document also covers immunogenicity, post-marketing adverse reactions, pharmacokinetic data, and submission requirements for BLA 103792/S-5337.
Key findings — cited to the page
| hot flashes (Grade 2-5) | 17.1% | Study 1 · p.18 |
| hot flashes (Grade 2-5) | 15.0% | Study 1 · p.18 |
| edema (Grade 2-5) | 2.7% | Study 1 · p.18 |
| Grade 3 or higher adverse reactions | 16.3% | Study 3 · p.18 |
| fatigue (Grade 2-5) | 22.4% | Study 1 · p.18 |
| fatigue (Grade 2-5) | 29.5% | Study 1 · p.18 |
| edema (Grade 2-5) | 4.7% | Study 1 · p.18 |
| infection (Grade 2-5) | 24.0% | Study 1 · p.18 |
| infection (Grade 2-5) | 12.8% | Study 1 · p.18 |
| Grade 3 or higher adverse reactions | 20.4% | Study 3 · p.18 |
| pain (Grade 2-5) | 3.0% | Study 1 · p.18 |
| anemia (Grade 2-5) | 12.3% | Study 1 · p.18 |
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 →