Posted by Michael Wonder on 06 Apr 2018
Stemline Therapeutics announces start of rolling BLA submission for SL-401
5 April 2018 - Stemline Therapeutics announced today that it has initiated its rolling submission of a biologics license application for SL-401 to the U.S. FDA.
SL-401 is a targeted therapy directed to CD123 that has been granted breakthrough therapy designation by the FDA.
SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123) present on a range of malignancies. SL-401 has completed a pivotal trial in blastic plasmacytoid dendritic cell neoplasm, for which it was granted breakthrough therapy designation. The pivotal trial met its primary endpoint, and a rolling submission has been initiated.
