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 Regimen Demonstrates Significant Progression-Free Survival Benefit in Advanced Colorectal Cancer

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Pfizer announced positive progression-free survival results from BREAKWATER trial Cohort 3, showing BRAFTOVI combined with cetuximab and FOLFIRI achieves statistically significant and clinically meaningful progression-free survival improvement compared to chemotherapy alone in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.

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.