Pfizer Inc. (PFE) said that the U.S. Food and Drug Administration has approved BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. Continued approval for the indication is contingent upon verification of clinical benefit.
The 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 indication was approved based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naïve patients treated with BRAFTOVI in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial.
The accelerated approval follows the previous FDA approval for BRAFTOVI in combination with cetuximab for adults with mCRC with a BRAF V600E mutation after prior therapy.
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