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FDA Approves Foundation Medicine CDx Tests for Pfizer's Braftovi-Mektovi Combo in Lung Cancer

NEW YORK – Roche subsidiary Foundation Medicine announced on Thursday that the US Food and Drug Administration has approved two of its companion diagnostic tests for use with Pfizer's Braftovi (encorafenib) in combination with Mektovi (binimetinib) for patients with metastatic non-small cell lung cancer with a BRAF V600E mutation. 

The FoundationOne CDx and FoundationOne Liquid CDx assays were approved to determine if NSCLC patients are eligible for treatment with the drug combination, which was also approved by the FDA this week. The kinase inhibitors were previously approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. 

The next-generation sequencing-based tests analyze more than 300 genes and are approved for multiple cancer indications. FoundationOne CDx uses DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens, while FoundationOne Liquid CDx utilizes circulating cell-free DNA from a blood sample. 

"We are thrilled to see both tests approved simultaneously for the same indication, which will expand access to this therapy option to more NSCLC patients who harbor a BRAF V600E mutation," Foundation Medicine Chief Medical Officer Mia Levy said in a statement.