The Cancer Letter

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Drugs & Targets

CPI-613 receives FDA Fast Track Designation for treatment of AML

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FDA has granted Fast Track designation to CPI-613 (devimistat) for the treatment of acute myeloid leukemia.

CPI-613 is sponsored by Rafael Pharmaceuticals Inc.

Rafael Pharmaceuticals received Fast Track designation for devimistat for the treatment of metastatic pancreatic cancer in November 2020. The company also received Orphan Drug Designation for the treatment of soft tissue sarcoma for devimistat, and the initiation of a phase II clinical trial of devimistat in combination with hydroxychloroquine in patients with clear cell sarcoma of soft tissue.

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