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FDA Approves Pfizer’s Braftovi Combination for First-Line Metastatic Colorectal Cancer

The decision is based on the Phase 3 Breakwater trial, which showed improvements in progression‑free and overall survival.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer Inc.’s Braftovi, or encorafenib, when used with Eli Lilly’s Erbitux (cetuximab) and fluorouracil‑based chemotherapy for adults with metastatic colorectal cancer carrying a BRAF V600E mutation. The decision is based on the Phase 3 Breakwater trial, which showed improvements in progression‑free and overall survival. The therapy previously received accelerated approval in December 2024 after demonstrating a higher ob...

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