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 cetuximab and Folfox as a first-line treatment option for adult patients with BRAFV600E-mutant mCRC. Discover B2B Marketing That Performs
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