Posted by Michael Wonder on 23 Aug 2016
Stemline Therapeutics receives breakthrough therapy designation from U.S. FDA for SL-401
23 August 2016 - Stemline Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation to SL-401.
SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123),for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).
This breakthrough therapy designation request was supported by efficacy and safety data from the Phase 2 trial evaluating SL-401in BPDCN patients in both the first-line and relapsed/refractory settings.
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, “We are very pleased that SL-401 has been granted Breakthrough Therapy Designation for BPDCN by the FDA. We continue to work closely with the agency in an effort to make this promising agent available to all BPDCN patients as quickly as possible. Given SL-401’s clinical activity in this CD123+ cancer, coupled with its manageable, non-overlapping safety profile with other oncology agents, we are also enthusiastic about the drug’s prospects in our other enrolling clinical trials in additional CD123+ indications as both a single agent and in combination. We expect to provide further updates around our multiple SL-401 clinical programs later this year.”
