FDA Grants Accelerated Approval to Braftovi for Some Patients With Metastatic Colorectal Cancer

The FDA granted accelerated approval to encorafenib (Braftovi, Array BioPharma, a subsidiary of Pfizer) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.

Efficacy was evaluated in BREAKWATER (ClinicalTrials.gov. Identifier: NCT04607421), an active-controlled, open-label, multicenter trial. Patients were required to have treatment-naive BRAF V600E mutation−positive mCRC, detected by the Qiagen