Roche Holding AG — Avastin EMA EPAR variation assessment report (EMEA/H/C/000582, 2005)
Roche Holding AG · 2005 · EMA EPAR variation assessment report · company profile →
Report summary
This report assesses a Type II variation for Avastin (bevacizumab) to treat platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The application is based on the Phase III GOG-0213 study, which investigated bevacizumab with carboplatin and paclitaxel. The study demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) in the overall population. While the benefit was less clear in patients previously treated with bevacizumab, and the initial GOG OS analysis didn't reach significance, the final results supported the efficacy. Safety analysis showed higher Grade 3/4 adverse events and discontinuations in the bevacizumab arm, consistent with its known safety profile, including bleeding and hypertension. Despite these safety concerns, the overall benefit-risk balance for this specific patient population was deemed positive, leading to updates in the Summary of Product Characteristics.
Key findings — cited to the page
| Patients with Grade 2 granulocytes in Crb+Pac arm | 96 % | Study GOG-0213 · p.54 |
| Patients with Grade ≥ 3 AEs in Crb+Pac+Bev arm (prior bevacizumab population) | 51.5 % | Study GOG-0213 · p.60 |
| Patients with Grade 2 haemoglobin in Crb+Pac arm | 98 % | Study GOG-0213 · p.54 |
| Patients with Grade 2 WBC in Crb+Pac+Bev arm | 95 % | Study GOG-0213 · p.54 |
| Patients with at least one AE (all grades) in Crb+Pac arm (prior bevacizumab population) | 97.1 % | Study GOG-0213 · p.59 |
| Patients with at least one AE (all grades) in Crb+Pac+Bev arm (prior bevacizumab population) | 100.0 % | Study GOG-0213 · p.59 |
| Patients with one or more AESIs of any grade in Crb+Pac+Bev arm | 73 % | Study GOG-0213 · p.47 |
| Patients with one or more AESIs of any grade in Crb+Pac arm | 23 % | Study GOG-0213 · p.47 |
| Patients with Grade 2 haemoglobin in Crb+Pac+Bev arm | 92 % | Study GOG-0213 · p.54 |
| Patients with Grade 2 WBC in Crb+Pac arm | 91 % | Study GOG-0213 · p.54 |
| Patients with Grade 2 granulocytes in Crb+Pac+Bev arm | 95 % | Study GOG-0213 · p.54 |
| Patients with Grade ≥ 3 AEs in Crb+Pac arm (prior bevacizumab population) | 37.1 % | Study GOG-0213 · p.60 |
Source: Roche Holding AG ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →