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[Opinion] CHMP Recommends BREAKWATER Regimen for Approval in 1L BRAF V600E+ mCRC
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Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colore
This positive CHMP opinion is based on results from the Phase 3 BREAKWATER trial, which showed that encorafenib in combination with cetuximab and mFOLFOX6 demonstrated a statistically significant improvement in the dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS), and a significant overall survival (OS) benefit, reducing the risk of death by […] The post Pierre Fabre Laboratories receives CHMP positive…
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