Selumetinib recommended for approval in the EU by CHMP as the first medicine for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
Recommendation based on the SPRINT Phase II trial, which showed selumetinib reduced tumour volume in childrenAstraZeneca and MSD’s selumetinib has been recommended for conditional marketing authorisation in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above.[1] NF1 is a debilitating genetic condition affecting 1 in 3,000 individuals worldwide.[2,3 ]In 30-50% of people with NF1, tumours develop on the nerve sheaths (plexiform neurofibromas) and can cause