Devimistat Gets FDA Fast Track Designation for Acute Myeloid Leukemia


The FDA has granted a fast track designation to devimistat (CPI-613) for the treatment of patients with acute myeloid leukemia.

The FDA has granted a fast track designation to devimistat (CPI-613) for the treatment of patients with acute myeloid leukemia (AML).1

“Receiving fast track designation, especially during a pandemic that has created significant challenges for many trials across the globe, is a testament to the dedicated work of the Rafael team,” Sanjeev Luther, president and CEO of Rafael Pharmaceuticals, Inc, stated in a press release. “We would not be here without the support of the FDA, our doctors, our patients, and all who are invested in the hope of finding a successful treatment for this hard-to-treat cancer.”

Devimistat was developed to selectively target the mitochondrial tricarboxylic acid (TCA) cycle in cancer cells, which is a process that is heavily involved with tumor cell proliferation and survival.2 The impact of the agent on the TCA cycle works to significantly increase the sensitivity of cancer cells to a wide range of chemotherapy agents; this also allows for the agent to be combined with lower doses of these agents to offer strong efficacy with fewer toxicities. In the multicenter, open-label, randomized phase 3 ARMADA trial (NCT03504410), investigators have set out to examine the efficacy and safety of devimistat in combination with high-dose cytarabine and mitoxantrone vs high-dose cytarabine and mitoxantrone and control subgroups comprised of mitoxantrone, etoposide, and cytarabine (MEC), as well as fludarabine, cytarabine, and filgrastim (FLAG) in older patients with relapsed/refractory AML.3,4

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