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A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients With Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) That Are Causing Significant Morbidity

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Trial Profile

A Phase 2b Trial of the MEK 1/2 Inhibitor (MEKi) PD-0325901 in Adult and Pediatric Patients With Neurofibromatosis Type 1 (NF1)-Associated Inoperable Plexiform Neurofibromas (PNs) That Are Causing Significant Morbidity

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Mirdametinib (Primary)
  • Indications Neurofibromatosis 1; Plexiform neurofibroma
  • Focus Registrational; Therapeutic Use
  • Acronyms ReNeu
  • Sponsors SpringWorks Therapeutics

Most Recent Events

  • 23 May 2025 According to a SpringWorks Therapeutics media release, the European Medicines Agencys (EMA) CHMP has adopted a positive opinion recommending the granting of a conditional marketing authorization for mirdametinib, for the treatment of symptomatic, inoperable PN in pediatric and adult patients with NF1 aged 2 years and above. The EC will review the CHMP opinion and is expected to make a final decision regarding the approval in the third quarter of 2025.
  • 20 Feb 2025 According to a SpringWorks Therapeutics media release, MAA for mirdametinib for the treatment of adults and children with NF1-PN is under review with the EMA. If approved, SpringWorks expects to begin its initial launch in the European Union in 2025.
  • 11 Feb 2025 According to a SpringWorks Therapeutics media release, the company was granted a rare pediatric disease priority review voucher (PRV) by the FDA.

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