Pfizer Reports the US FDA’s Acceptance of sNDA for Braftovi + Mektovi to Treat Metastatic Non-Small Cell Lung Cancer
Shots:
- The US FDA has accepted the sNDAs for review of Braftovi + Mektovi for patients with metastatic NSCLC with a BRAF V600E mutation. The US FDA’s decision is expected in Q4’23
- The sNDAs were based on the P-II trial (PHAROS) evaluating Braftovi (BRAF kinase inhibitor) + Mektovi (MEK inhibitor) in 98 patients across 53 sites in Italy, the Netherlands, South Korea, Spain & the US. The trial met its 1EPs of ORR & the results will be presented at an upcoming scientific congress
- The company gets an exclusive right to Braftovi & Mektovi in the US, Canada & all countries in Latin America, Africa & Middle East regions. The combination therapy was approved for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation in the US
Ref: fda | Image: fda
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