On August 23, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported 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) (Press release, Stemline Therapeutics, AUG 23, 2016, View Source [SID:1234514678]). Schedule your 30 min Free 1stOncology Demo! 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.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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."