Stemline's Elzonris get FDA nod, first therapy for rare blood disorder

FDA approved Elzonris tagraxofusp-erzs (SL-401) from Stemline Therapeutics Inc. (NASDAQ:STML) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in patients ages two and older, making it the indication's first approved therapy.

Stemline CEO Ivan Bergstein told BioCentury it plans to launch the therapy in early 2019. Robert Francomano, SVP and global head of commercial, said during a conference call Dec. 21 that the wholesale acquisition cost (WAC) is $24,430 per 1 mg vial. Francomano went on to say that patients used a median of 21 vials in the pivotal portion of the Phase II trial on which FDA based its approval...