SpringWorks Therapeutics announced on November 11, 2024, that data from the pivotal Phase 2b ReNeu trial of mirdametinib in adults and children with NF1-PN were published in the Journal of Clinical Oncology. The data demonstrated significant confirmed objective response rates and a manageable safety profile.
The ReNeu trial met its primary endpoint, showing an objective response rate (ORR) of 41% in adults and 52% in children. Patients achieved deep and durable reductions in tumor volume, alongside early, sustained, and clinically meaningful improvements in pain and health-related quality of life.
Further data from the ReNeu trial and a Phase 1/2 study of mirdametinib in pediatric low-grade gliomas were presented at the 2024 Society for Neuro-Oncology Annual Meeting. The New Drug Application (NDA) for mirdametinib in NF1-PN was granted Priority Review by the FDA with a PDUFA action date of February 28, 2025, and the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA).
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