Stemline agrees with FDA registration pathway for SL 401 (stem cell therapy) to treat blastic plasmacytoid dendritic cell neoplasm.
Stemline Therapeutics, Inc.announced an agreement with the 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 II 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 second half of 2017, 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.
Comment:Blastic plasmacytoid dendritic cell neoplasm (BPDCN), previously known as natural killer (NK) cell leukemia/lymphoma, is categorized by the World Health Organization (4th edition, 2008) under acute myeloid leukemia (AML). Most often, BPDCN presents with features of both lymphoma and leukemia. There are little data about BPDCN and there is no established treatment. The average age at diagnosis is 60 to 70 years. There are more men than women who are diagnosed with BPDCN.
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