7 January 2019 - Stemline Therapeutics announced today that it has submitted the marketing authorisation application for Elzonris (tagraxofusp) to the EMA. 

The MAA seeks approval for treating patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the EMA granted the Elzonris MAA accelerated assessment.

On December 21, 2018, Elzonris was approved by the U.S. FDA for the treatment of BPDCN in adult and paediatric patients, two years and older, in both treatment-naïve and previously-treated populations. Elzonris is the first treatment approved for BPDCN and the first approved CD123-targeted therapy.

Read Stemline Therapeutics press release