FDA accepts submission for selumetinib as treatment for neurofibromatosis

(Children's Tumor Foundation) The FDA granted acceptance to file status for selumetinib, for use in patients with plexiform neurofibromas, a common manifestation in neurofibromatosis type one (NF1). This is a key milestone for becoming the first approved treatment for NF. This follows previous designations granting orphan drug status as well as breakthrough status, and enters the drug into the FDA's approval pipeline. The FDA also granted priority review, and a PDUFA has been set for Q2 of 2020.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news