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Stemline Therapeutics Announces Positive FDA Meeting and Agreement on Expedited Pathway to Full Approval of SL-401 in First-Line BPDCN


  • Ongoing Phase 2 trial with additional small cohort (8-12 patients planned) sufficient for BLA filing for full approval
  • Approximately half of new cohort patients already enrolled, with full enrollment expected this quarter
  • BLA filing targeted for 2H17, with commercial launch projected for 2018
  • Conference call scheduled for tomorrow, Friday, January 6 at 8:00 AM ET

Stemline Therapeutics, Inc. STML, -4.62% announced today an agreement with the U.S. Food and Drug Administration (FDA) on the registration pathway for SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN). To support the filing of a Biologics License Application (BLA) for full approval in first-line BPDCN, Stemline is currently enrolling an additional small cohort, planned for 8-12 first-line BPDCN patients, into its ongoing Phase 2 trial. To date, approximately half of these new patients are enrolled into the study, with full enrollment expected this quarter. Stemline intends to file a BLA in 2H17, which is anticipated to undergo an expedited review given SL-401's Breakthrough Therapy Designation. If successful, Stemline projects a commercial launch of SL-401 in 2018.

Ivan Bergstein, M.D., Stemline's Chief Executive Officer, commented, "We are extremely pleased with the outcome of our meeting with the FDA and the Agency's continued guidance regarding SL-401, which was granted Breakthrough Therapy Designation this past August. The Agency has now provided us with a clear and potentially rapid pathway to obtain full approval of SL-401 in first-line BPDCN, as well as the possibility for review in the relapsed/refractory setting. We are actively enrolling patients who are to be included in the final cohort of the trial and are targeting completion of enrollment this quarter." Dr. Bergstein continued, "In parallel, our operations and regulatory teams are working...