Pfizer’s BRAFTOVI Receives FDA Full Approval for First-Line Metastatic Colorectal Cancer Treatment

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Pfizer announced FDA full approval of BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for treating adults with BRAF V600E-mutant metastatic colorectal cancer. The landmark approval is backed by Phase 3 BREAKWATER trial data demonstrating a 51% reduction in mortality risk and 47% reduction in disease progression risk compared to standard chemotherapy.

Pfizer’s BRAFTOVI® Combination Regimen Halves Mortality Risk in BRAF V600E-Mutant Metastatic Colorectal Cancer

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Pfizer’s BRAFTOVI® combination regimen has demonstrated a 51% reduction in the risk of death and a 47% decrease in disease progression for patients with BRAF V600E-mutant metastatic colorectal cancer, according to the pivotal Phase 3 BREAKWATER trial.

Combination of chemotherapy and dual-targeted treatments Phase III Breakwater Clinical trials supported for BRAF-mutated metastatic colorectal cancer FDA approval

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Data from this 28-country multi-institutional effort helped the Food and Drug Administration (FDA) approve this combination more quickly in December 2024, giving patients with BRAF V600E-mutant mCRC a new and effective first-line treatment choice.