Merck B V — Erbitux EMA EPAR variation assessment report (EMEA/H/C/000558, 2004)
Merck B V · 2004 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation application for Merck Europe B.V.'s Erbitux (cetuximab) to extend its indication for first-line treatment of BRAF V600E mutant metastatic colorectal cancer. The application, based on interim results from the Phase 3 BREAKWATER study, proposes Erbitux in combination with encorafenib and mFOLFOX6 (EC+mFOLFOX6). The BREAKWATER study demonstrated statistically significant improvements in progression-free survival, overall survival, and objective response rate for the EC+mFOLFOX6 arm compared to standard-of-care. While the combination increased some manageable toxicities, no new safety concerns were identified.
Key findings — cited to the page
| Grade 3-4 events | 85.8 % | BREAKWATER · p.78 |
| Incidence of adverse events of grade 3 or 4 | 85.8 % | · p.79 |
| Grade 3-4 events | 71.2 % | BREAKWATER · p.78 |
| Incidence of adverse events of grade 3 or 4 | 71.2 % | · p.79 |
| Incidence of discontinuations due to adverse events | 6.9 % | · p.79 |
| Incidence of discontinuations due to adverse events | 17.0 % | · p.79 |
| median OS (months) | 30.3 months | BREAKWATER · p.77 |
| Incidence of serious adverse events | 38.9 % | · p.79 |
| median PFS (months) | 7.1 months | BREAKWATER · p.77 |
| Incidence of serious adverse events | 46.1 % | · p.79 |
| Incidence of AEs leading to death | 4.4 % | · p.79 |
| Incidence of AEs leading to death | 4.3 % | · p.79 |
Source: Merck B V ↗ · 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 →