Press Release

December 21, 2020
1 min read

FDA grants fast track designation to CPI-613 for AML


Press Release

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The FDA granted fast track designation to devimistat for treatment of acute myeloid leukemia, according to the agent’s manufacturer.

Devimistat (CPI-613, Rafael Pharmaceuticals) targets enzymes in the mitochondria of cancer cells that are involved in cancer cell energy metabolism.

The agent is designed to selectively target the mitochondrial tricarboxylic acid cycle in cancer cells. This process is essential to tumor cell multiplication and survival.

“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, said in a company-issued 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.”

In November, the FDA granted fast track designation to devimistat for treatment of metastatic pancreatic cancer.

The agency also granted orphan drug designation to the agent for treatment of AML, pancreatic cancer, soft tissue sarcoma, myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt lymphoma.

The FDA gave Rafael Pharmaceuticals approval to launch the phase 3 ARMADA 2000 trial to evaluate devimistat for the treatment of AML.

Jorge Cortes, MD
Jorge Cortes

“This designation underscores the pressing need to find new ways to combat this aggressive disease,” principal investigator Jorge Cortes, MD, director of Georgia Cancer Center at Augusta University, said in the release .“It brings hope not only to clinicians, but to patients who hear that they have been diagnosed.”