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# Pfizer Seeks Braftovi Full Approval in Colon Cancer
- URL: https://www.fdaweb.com/pfizer-seeks-braftovi-full-approval-in-colon-cancer/
- Published: 2025-02-03T12:00:00.000Z
- Updated: 2026-09-14T14:52:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158592

Pfizer says it will seek full approval for current accelerated-approved Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer harboring a BRAF V600E mutation. The decision to seek full approval is based on positive data from the confirmatory Phase 3 BREAKWATER study that Pfizer says showed a statistically significant and clinically meaningful improvement in progression-free survival in Braftovi-treated patients compared to patients receiving chemotherapy with or without bevacizumab. “Further, the Braftovi combination regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival, a key secondary endpoint in the trial,” the company says.