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FDA Approves BRAFTOVI® Combination Regimen as First-Line Treatment for BRAF V600E-Mutant Metastatic Colorectal Cancer

NextEdge Admin

21 Dec 2024

2 min 37 sec

colorectal cancer,BRAF mutations,Precision medicine

Pfizer Inc. announced FDA approval for BRAFTOVI® (encorafenib) combined with cetuximab (ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, oxaliplatin) to treat metastatic colorectal cancer (mCRC) with the BRAF V600E mutation, detected via an FDA-approved test. This approval is based on the Phase 3 BREAKWATER trial, which demonstrated a statistically significant improvement in response rate and durability compared to standard care. It is part of the FDA’s Project FrontRunner, aimed at expediting advanced cancer drug approvals.

The BREAKWATER trial showed a 61% overall response rate (ORR) for the BRAFTOVI regimen, compared to 40% for standard chemotherapy, with median durations of response at 13.9 months and 11.1 months, respectively. The safety profile was consistent with known effects of the individual agents, with common adverse reactions including neuropathy, nausea, fatigue, and rash. Serious adverse events led to permanent discontinuation of BRAFTOVI in 12% of patients.

BRAF mutations, present in 8-10% of mCRC cases, are linked to aggressive disease and poor prognosis. The BRAF V600E mutation specifically doubles mortality risk compared to non-mutated cases. Previously, no first-line biomarker-driven therapies were available for untreated mCRC with this mutation.

“This approval offers renewed hope for mCRC patients with BRAF V600E mutations,” said Dr. Scott Kopetz of MD Anderson Cancer Center. Pfizer’s Chris Boshoff highlighted the milestone as part of the company’s ongoing innovation in BRAF-targeted treatments.

Colorectal cancer, the third most common cancer globally, has significant unmet needs, particularly for metastatic cases. With the BRAFTOVI regimen now approved, patients with BRAF V600E-mutant mCRC have a new first-line option for treatment, offering a promising step forward in addressing this challenging disease.