FDA approves new use for Pfizer’s Braftovi combo

US pharma giant Pfizer (NYSE: PFE) on Friday revealed that the US Food and Drug Administration (FDA) has approved its Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.

This approval was 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, marketed by Eli Lilly (NYSE: LLY) as Erbitux, and mFOLFOX6 from the Phase III 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.

Pfizer acquired rights to the drug along with its $11.4 billion buy of Array BioPharma.