Stemline Therapeutics Announces Start of Rolling BLA Submission for SL-401

Stemline Therapeutics announced that it has initiated its rolling submission of a Biologics License Application (BLA) for SL-401 to the U.S. Food and Drug Administration (FDA). SL-401 is a targeted therapy directed to CD123 that has been granted Breakthrough Therapy designation (BTD) by the FDA.

Ivan Bergstein, MD, CEO of Stemline, commented, “The start of our rolling BLA submission is a major milestone for Stemline and the BPDCN patient community at large. If successful, SL-401 would be the first drug ever approved for BPDCN. Moreover, we believe that SL-401 may have a transformative impact on the outcomes of patients with this lethal malignancy of high unmet medical need. With this in mind, our clinical, regulatory, manufacturing, and commercial teams continue to work expeditiously to bring SL-401 to patients as quickly as possible.”