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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: 06 Mar 2024

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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

    • 04 Mar 2024 Results(As of the data cutoff date of September 20, 2023) presented in the Media Release.
    • 04 Mar 2024 According to a SpringWorks Therapeutics media release, company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) and look forward to working closely with the FDA on their review of our application.SpringWorks expects to complete the NDA submission in the second quarter of 2024.
    • 16 Nov 2023 According to a SpringWorks Therapeutics media release, additional data are expected to be presented at an upcoming medical conference in the first half of 2024 and to be submitted for publication in a peer-reviewed journal.
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