Koselugo approved in the EU for plexiform neurofibromas in adults with neurofibromatosis type 1

AstraZeneca

28 August 2025 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour size reduction.

Alexion, AstraZeneca Rare Disease’s Koselugo (selumetinib), an oral, selective MEK inhibitor, has been approved in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas in adult patients with neurofibromatosis type 1.

Read AstraZeneca press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , Registration