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Feb 25, 2026 4:01 PM

Pfizer's Braftovi Regimen Wins Complete FDA Nod For Colorectal Cancer Treatment

Pfizer Inc. (NYSE:PFE) shares are trending on Wednesday following the U.S. Food and Drug Administration’s (FDA) full approval of the BRAFTOVI combination regimen for treating metastatic colorectal cancer.

The positive news comes as the broader market is experiencing gains, with the S&P 500 up 0.53% today, indicating a favorable environment for stocks.

Complete FDA Approval For Mutated Colorectal Cancer

The FDA granted full approval to Braftovi (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for adult patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation.

In December 2024, the FDA granted accelerated approval to Braftovi in combination with cetuximab and mFOLFOX6 for BRAF V600E-mutant mCRC.

The approval is based on results from the Phase 3 BREAKWATER trial, which demonstrated significant improvements in progression-free survival and overall survival.

In January, the Braftovi combination regimen with FOLFIRI and cetuximab demonstrated a clinically meaningful and