U.S. FDA Grants Full Approval to Pfizer's BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial (NCT04607421). BRAFTOVI in combination with cetuximab and mFOLFOX6 was granted. ...