Koselugo, an oral, selective MEK inhibitor, has been recommended for approval in the European Union, EU, for the treatment of symptomatic, inoperable plexiform neurofibromas, PN, in adult patients with neurofibromatosis type 1, NF1. The Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, based its positive opinion on results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient population, which were presented at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and published in The Lancet. In the primary analysis of the trial, Koselugo showed a statistically significant objective response rate, ORR, of 20% compared to 5% with placebo by cycle 16.
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