Laboratoires Pierre Fabre announces that the European Commission has approved BRAFTOVI® (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin and oxaliplatin) for the first-line treatment of adult patients with metastatic colorectal cancer whose tumors carry a BRAFV600E mutation. The approval is based on results from the Phase 3 BREAKWATER trial. According to the company’s statements, encorafenib combined with cetuximab and mFOLFOX6 (a defined FOLFOX regimen) improves two co-primary endpoints in a statistically significant manner: objective response rate (ORR) and a second primary measure reported by the trial, alongside confirmation of the regimen’s activity in the targeted patient population. The outlets consistently describe this decision as an EU authorization for use up front (first-line) and emphasize that it follows evidence from the BREAKWATER study. All sources present the same regimen components—encorafenib plus cetuximab, combined with FOLFOX/mFOLFOX6—for eligible adults with BRAFV600E-mutated metastatic colorectal cancer.
European Commission approves BRAFTOVI plus cetuximab and FOLFOX for first-line BRAFV600E metastatic colorectal cancer
Laboratoires Pierre Fabre announces that the European Commission has approved BRAFTOVI® (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin and oxaliplatin) for the first-...
- The European Commission approves BRAFTOVI® (encorafenib) combined with cetuximab and FOLFOX (fluorouracil, leucovorin and oxaliplatin) as first-line therapy.
- The indicated population is adult patients with metastatic colorectal cancer with a BRAFV600E mutation.
- The approval is based on Phase 3 BREAKWATER trial results.
- The trial shows statistically significant improvement on two co-primary endpoints, including objective response rate (ORR).
- The study regimen is described as encorafenib with cetuximab plus mFOLFOX6.
Die europäische Zulassung stützt sich auf die Ergebnisse der Phase-3-Studie BREAKWATER, die zeigte, dass Encorafenib in Kombination mit Cetuximab und mFOLFOX6 eine statistisch signifikante Verbesserung bei den beiden primären Endpunkten – der objektiven Ansprechrate (ORR) und dem...
18 hours agoL'approvazione europea si basa sui risultati dello studio di fase 3 BREAKWATER, che ha dimostrato che encorafenib in combinazione con cetuximab e mFOLFOX6 ha mostrato un miglioramento statisticamente significativo nei doppi endpoint primari, ovvero il tasso di risposta obiettiva (ORR) e...
19 hours agoLaboratoires Pierre Fabre recibe la aprobación de la Comisión Europea para BRAFTOVI® (encorafenib) en combinación con cetuximab y FOLFOX (fluorouracilo, leucovorina y oxaliplatino) para el tratamiento de primera línea de pacientes adultos con cáncer colorrectal metastásico (CCRM) con...
19 hours agoCette approbation de la Commission européenne se base sur les résultats de l'essai de phase 3 BREAKWATER, qui a confirmé que l'encorafenib associé au cetuximab et à mFOLFOX6 démontrait une amélioration statistiquement significative des deux co-critères principaux, le taux de réponse...
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