Posted by Michael Wonder on 22 Sep 2025
Koselugo recommended for approval in the EU by CHMP for plexiform neurofibromas in adults with neurofibromatosis type 1
22 September 2025 - Recommendation based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour size reduction.
Koselugo (selumetinib), an oral, selective MEK inhibitor, has been recommended for approval in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas in adult patients with neurofibromatosis type 1.
