US FDA accepts Pfizer sNDA for Braftovi + Mektovi for patients with metastatic NSCLC

Pfizer Inc. announced that the US Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for Braftovi (encorafenib) + Mektovi (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in fourth-quarter 2023 for the sNDAs. In the US, Braftovi + Mektovi is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Braftovi is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

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