Pfizer: FDA accepts sNDAs for BRAFTOVI + MEKTOVI

Pfizer announced that the U.S. FDA has accepted for review the Supplemental New Drug Applications for BRAFTOVI + MEKTOVI for patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test. The Prescription Drug User Fee Act goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. In the U.S., 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 with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.