[Opinion] Pierre Fabre’s Braftovi gains CHMP positive opinion for mCRC
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4 Articles
Data shows survival benefit in BRAFV600E‑mutant metastatic colorectal cancer
Pierre Fabre’s Braftovi gains CHMP positive opinion for mCRC
The EMA's CHMP has issued a positive opinion recommending approval of Pierre Fabre Laboratories’ Braftovi to treat mCRC with BRAFV600E mutations.
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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