FDA accepts AstraZeneca-Merck selumetinib marketing application

The FDA accepts under Priority Review a marketing application seeking approval of AstraZeneca (NYSE:AZN) and collaboration partner Merck’s (NYSE:MRK) MEK 1/2 inhibitor selumetinib for the treatment of pediatric patients at least three years old with neurofibromatosis type 1 (NF1) and symptomatic inoperable plexiform neurofibromas (tumors that are a common complication of NF1).

The agency’s action date is in Q2 2020.

NF1 is a rare inherited disorder characterized by changes in skin coloring and tumor growth along nerves in the skin, brain and other parts of the body.

https://seekingalpha.com/news/3519133-fda-accepts-selumetinib-marketing-application-nf1