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FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation

October 16, 2023 4:09 PM | Katy Monaco (Administrator)

Food and Drug Administration approved encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) 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. Read More

View full prescribing information for Braftovi and Mektovi.


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