Pfizer’s colorectal cancer combo therapy gains accelerated approval from FDA (Pharmaceutical Technology)

Pfizer has received FDA accelerated approval for BRAFTOVI (encorafenib) combined with cetuximab and mFOLFOX6 to treat metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as confirmed by an FDA-approved test. The approval, part of the FDA’s Project FrontRunner initiative, is based on the Phase III BREAKWATER trial, which showed a 61% response rate with the BRAFTOVI regimen compared to 40% in the control arm. Further trials are ongoing to confirm long-term clinical benefits. Pfizer continues global regulatory discussions to expand approvals and is exploring next-generation BRAF inhibitors for broader cancer treatments.