Mirdametinib (Gomekli) wins FDA approval, bringing relief to NF-1 patients with surgically inoperable plexiform neurofibromatosis worldwide

Memuna J. Zeb

Malignancy Spectrum ›› 2025, Vol. 2 ›› Issue (3) : 171 -172.

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Malignancy Spectrum ›› 2025, Vol. 2 ›› Issue (3) : 171 -172. DOI: 10.1002/msp2.70020
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Mirdametinib (Gomekli) wins FDA approval, bringing relief to NF-1 patients with surgically inoperable plexiform neurofibromatosis worldwide

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Memuna J. Zeb. Mirdametinib (Gomekli) wins FDA approval, bringing relief to NF-1 patients with surgically inoperable plexiform neurofibromatosis worldwide. Malignancy Spectrum, 2025, 2(3): 171-172 DOI:10.1002/msp2.70020

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Canadian Agency for Drugs and Technologies in Health . CADTH Reimbursement Recommendation. 2023.

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U.S. Food and Drug Administration . FDA Approves Mirdametinib for Adult and Pediatric Patients With Neurofibromatosis Type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection. Accessed February 21 2025.

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Weiss BD , Wolters PL , Plotkin SR , et al. NF106:a neuro-fibromatosis clinical trials consortium phase II trial of the MEK inhibitor mirdametinib (PD-0325901) in adolescents and adults with NF1-related plexiform neurofibromas. J Clin Oncol. 2021; 39 (7): 797- 806.

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Moertel CL , Hirbe AC , Shuhaiber HH , et al. ReNeu:a pivotal, phase IIb trial of mirdametinib in adults and children with symptomatic neurofibromatosis type 1-associated plexiform neurofibroma. J Clin Oncol. 2025; 43 (6): 716- 729.

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