FDA Approves Braftovi With Mektovi for Metastatic NSCLC With a BRAF V600E Mutation

The FDA approved encorafenib (Braftovi, Array BioPharma, a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

The FDA also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib. If no mutation is detected in a plasma specimen, the tumor tissue should be