Sanofi — Zaltrap EMA EPAR public assessment report (EMEA/H/C/002532, 2013)
Sanofi · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The CHMP recommended aflibercept (Zaltrap) for metastatic colorectal cancer in November 2012, based on the VELOUR trial. This trial demonstrated a modest but clinically significant improvement in median overall survival of 1.44 months and an 18% reduction in the risk of death when aflibercept was combined with FOLFIRI, compared to placebo plus FOLFIRI. While significant toxicity was observed, the benefits were deemed to outweigh the risks. The clinical safety profile of Zaltrap in combination with FOLFIRI showed increased rates of treatment discontinuation, dose modifications, and adverse events. Key safety concerns included hemorrhage, gastrointestinal perforation, hypertension, and thromboembolic events. A pharmacovigilance plan and risk minimization strategies were outlined to address these identified risks.
Key findings — cited to the page
| Grade 3-4 TEAEs (aflibercept arm) | 83.5 % | · p.76 |
| Grade 3-4 TEAEs (placebo arm) | 62.5 % | · p.76 |
| pivotal safety population (placebo arm) | 605 patients | EFC10262 · p.76 |
| pivotal safety population (aflibercept arm) | 611 patients | EFC10262 · p.76 |
| permanent treatment discontinuation due to AEs (aflibercept arm) | 26.8 % | · p.76 |
| permanent treatment discontinuation due to AEs (placebo arm) | 12.1 % | · p.76 |
| p-value for HR | 0.0032 | EFC10262- VELOUR · p.2 |
| patients in integrated safety database (placebo) | 1354 | · p.76 |
| Serious TEAEs (aflibercept arm) | 48.1 % | · p.76 |
| Serious TEAEs (placebo arm) | 32.7 % | · p.76 |
| deaths from AE (aflibercept arm) | 2.3 % | · p.76 |
| patients in integrated safety database (aflibercept) | 2073 | · p.76 |
Source: Sanofi ↗ · 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 →