FDA nod for sNDA on Braftovi combo for metastatic colorectal cancer with a BRAF V600E mutation

The Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Braftovi (encorafenib) from Array BioPharma, which was acquired last July by Pfizer (NYSE: PFE) in an $11.4 billion deal.

Braftovi is approved for use in combination with cetuximab, Eli Lilly’s (NYSE: LLY) Erbitux, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy.

Efficacy was evaluated in a randomized, active-controlled, open-label, multicenter trial (BEACON CRC; NCT02928224). Eligible patients were required to have BRAF V600E mutation-positive metastatic CRC (detected by the Qiagen therascreenBRAF V600E RGQ PCR kit) with disease progression after one or two prior regimens. A total of 220 patients were randomized to encorafenib (300 mg orally once daily) in combination with cetuximab and 221 patients were randomized to the control arm of either irinotecan or FOLFIRI with cetuximab.