FDA grants fast track designation to CPI-613 for AML

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.

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