Aptose Biosciences Inc. on Wednesday said the U.S. Food and Drug Administration granted fast-track designation to HM43239 for the treatment of patients with relapsed or refractory acute myeloid leukemia with FLT3 mutation.
The Toronto clinical-stage oncology company is currently conducting a Phase 1/2 study of HM43239 in patients with the cancer of the blood and bone marrow.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs. The agency previously granted orphan-drug designation to HM43239 for treatment of acute myeloid leukemia in 2018.
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