News
10 Mar 2011
ShareThisStemline AML Drug Granted Orphan Status
Stemline Therapeutics, Inc. announced that SL-401, the Company's lead compound, has received Orphan Drug designation from the FDA for the treatment of acute myeloid leukemia (AML).
Stemline Therapeutics’ lead compound SL-401 has received Orphan Drug designation from FDA for the treatment of acute myeloid leukemia (AML). The approval helps to support the development of new therapies that treat rare diseases and offers incentives such as seven years of marketing exclusivity, tax credits, and clinical development grants, as well as a waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
SL-401 has completed a multi-center Phase I/II trial in AML demonstrating single agent efficacy, including two durable complete responses (CRs), multiple blast reductions and disease stabilizations, as well as an overall survival (OS) benefit in heavily pre-treated patients. SL-401 was well tolerated and bone marrow-sparing. SL-401 will now enter Phase III trials in patients with advanced AML.
SL-401 has completed a multi-center Phase I/II trial in AML demonstrating single agent efficacy, including two durable complete responses (CRs), multiple blast reductions and disease stabilizations, as well as an overall survival (OS) benefit in heavily pre-treated patients. SL-401 was well tolerated and bone marrow-sparing. SL-401 will now enter Phase III trials in patients with advanced AML.
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