Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for BRAFTOVI (encorafenib) in combination with cetuximab and mFOLFOX6. This regimen is approved for the first-line treatment of patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation, as detected by an FDA-approved test.
The approval is based on a statistically significant and clinically meaningful improvement in response rate and durability of response observed in treatment-naïve patients from the Phase 3 BREAKWATER trial. The objective response rate (ORR) for the BRAFTOVI combination was 61%, compared to 40% for chemotherapy, with a median duration of response (DoR) of 13.9 months versus 11.1 months.
This accelerated approval, conducted under the FDA’s Project FrontRunner, provides a new targeted therapy option for patients with previously untreated BRAF V600E-mutant mCRC, an aggressive form of cancer with historically limited treatment options. The safety profile of the combination was consistent with known profiles of each agent, with no new safety signals identified.
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