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. The CHMP opinion is based on results from the Phase III BREAKWATER trial. In the Phase III trial, the combination improved progression-free survival statistically and clinically. Credit: Motortion Films / Shutterstock.com. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Pierre Fabre Laboratories’ Braftovi (encorafenib) for the treatment of metastatic colorectal cancer (mCRC) with BRAFV600E mutations. The recommendation covers the use of the therapy in combination with…

Salong Debbarma · 2026-05-26

The EMA's CHMP has issued a positive opinion recommending approval of Pierre Fabre Laboratories’ Braftovi to treat mCRC with BRAFV600E mutations.

Source: Pharmaceutical Technology