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Pfizer Reports the US FDA’s Acceptance of sNDA for Braftovi + Mektovi to Treat Metastatic Non-Small Cell Lung Cancer

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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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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