Pfizer (PFE) announced that the Food and Drug Administration has approved Braftovi in combination with cetuximab and mFOLFOX6 for the treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test. The indication was approved based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naive patients treated with Braftovi in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial. “Continued approval for this indication is contingent upon verification of clinical benefit. This accelerated approval is among the first in the industry to be conducted under the FDA’s Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease,” the company stated.
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