AstraZeneca's Koselugo (selumetinib) has been approved in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas in adult patients with neurofibromatosis type 1.
The approval is based on results from the KOMET trial, a placebo-controlled global Phase III trial, presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in The Lancet.
The European Commission's approval follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).
Koselugo is an oral, selective MEK inhibitor, developed by Alexion, AstraZeneca Rare Disease.
Author's summary: Koselugo approved in EU for neurofibromatosis type 1 treatment.