AstraZeneca's Selumetinib Capsules Received CDE Priority Review

Today, the CDE official website announced that AstraZeneca's Selumetinib Capsules will be included in priority review. Selumetinib is the world's first drug approved for the treatment of neurofibromatosis type 1 plexiform neurofibromas (PN) in pediatric practice.

Selumetinib is an oral selective inhibitor of the MEK enzyme, one of the components of the mitogen-activated protein kinase (MAPK) signaling pathway, which blocks the enzyme to inhibit cell growth and proliferation. The drug showed high efficacy in the SPRINT clinical study in children 2 to 18 years of age with NF1 and inoperable PN. Selumetinib not only reduced tumor volume in some children, but also reduced pain and improved quality of life in patients.

In June 2021, the European Commission (EC) conditionally approved Selumetinib for the treatment of symptomatic, inoperable plexiform neurofibromas in pediatric patients 3 years of age and older with neurofibromatosis type 1 (NF1).