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CHMP Backs Mirdametinib for Neurofibromatosis Treatment Approval

5/24/2025

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Story summary
  • The CHMP has put its weight behind mirdametinib as a potential treatment for inoperable plexiform neurofibromas in both adults and children suffering from neurofibromatosis type 1. With a promising 41% response rate in adults and 52% in children from the ReNeu trial, the European Commission's decision on approval is eagerly awaited by Q3 2025.