By VETTAPHARMA reporter – Derek Roche: Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, based on results from the global Phase 3 BREAKWATER trial (NCT04607421).
The BRAFTOVI combination regimen is the only approved targeted regimen for first-line BRAF V600E-mutant metastatic colorectal cancer.
This full approval converts the regimen’s previous accelerated approval from December 2024 — which was granted based on objective response rate (ORR) results — into a traditional full approval.
The decision by the FDA reflects significant benefit in progression-free survival (PFS) and overall survival (OS) demonstrated in the Phase 3 BREAKWATER study when comparing the BRAFTOVI combination with standard chemotherapy.
According to Pfizer’s announcement, expanded indications now empower oncologists to use BRAFTOVI with cetuximab and different fluorouracil-based chemotherapy regimens in the first-line setting, setting a new standard of care for patients with this aggressive cancer subtype.
