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U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer

NEW YORK, February 24, 2026--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).

articlePfizer, Inc.February 24, 202617/company/pfizer-inc/news/us-fda-grants-full-approval-to-pfizers-braftovi-combination-regimen-in-first-line-metastatic-colorectal-cancer
U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer

About this update from Pfizer, Inc.

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metastatic colorectal cancerFOLFIRImetastatic colorectal cancerBRAFBRAFTOVIcombination regimencancerCancer