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FDA grants breakthrough therapy designation to SL-401
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The FDA granted breakthrough therapy designation to SL-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm.
SL-401 (Stemline Therapeutics) — a targeted therapy directed to the interleukin-3 receptor (CD123) — has demonstrated high overall response rates, including complete responses, in an ongoing trial of patients with blastic plasmacytoid dendritic cell neoplasm.
“We are very pleased that SL-401 has been granted breakthrough therapy designation for blastic plasmacytoid dendritic cell neoplasm by the FDA,” Ivan Bergstein, MD, CEO of Stemline Therapeutics, said in a press release. “We continue to work closely with the agency in an effort to make this promising agent available to all blastic plasmacytoid dendritic cell neoplasm patients as quickly as possible.”
Phase 2 trials also are ongoing to evaluate SL-401 in patients with acute myeloid leukemia that is in remission but at high risk for relapse, as well as in patients with advanced, high-risk myeloproliferative neoplasms of unmet medical need.
Further, researchers are enrolling patients with relapsed/refractory multiple myeloma onto a phase 1/phase 2 trial to evaluate SL-401 in combination with standard therapies.
“Given SL-401’s clinical activity in this CD123–positive cancer, coupled with its manageable, nonoverlapping safety profile with other oncology agents, we are also enthusiastic about the drug’s prospects in our other enrolling clinical trials in additional CD123–positive indications as both a single agent and in combination,” Bergstein said. “We expect to provide further updates around our multiple SL-401 clinical programs later this year.”