Stemline Therapeutics' (STML) SL-401 Receives FDA Breakthrough Therapy Designation as BPDCN Treatment

August 23, 2016 7:32 AM EDT

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Stemline Therapeutics, Inc. (Nasdaq: STML) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to SL-401, a targeted therapy directed to the interleukin-3 receptor (CD123), for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require clinical evidence demonstrating the drug may offer substantial improvement on one or more clinically significant endpoints versus existing therapies.

This Breakthrough Designation request was supported by efficacy and safety data from the Phase 2 trial evaluating SL-401 in 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.”

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