11 October 2023 - Today, 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 with a BRAF V600E mutation, as detected by an FDA approved test.
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 tested.