Posted by Michael Wonder on 26 Apr 2021
Selumetinib recommended for approval in the EU by CHMP as the first medicine for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
26 April 2021 - Recommendation based on the SPRINT Phase 2 trial, which showed selumetinib reduced tumour volume in children.
AstraZeneca and MSD’s selumetinib has been recommended for conditional marketing authorisation in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas in paediatric patients with neurofibromatosis type 1 aged three years and above.
