November 16, 2020
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FDA grants fast track designation to CPI-613 for pancreatic cancer

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The FDA granted fast track designation to devimistat for the treatment of pancreatic cancer, 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.

Pancreas as a puzzle
Source: Adobe Stock.

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 is a significant milestone in our fight against pancreatic cancer,” Sanjeev Luther, president and CEO of Rafael Pharmaceuticals, said in a company-issued press release. “This designation further stresses the severe unmet need in treatment options for this aggressive and devastating disease.”

The FDA gave Rafael Pharmaceuticals approval to begin pivotal phase 3 trials in pancreatic cancer and acute myeloid leukemia.

Philip A. Philip, MD, PhD, FRCP
Philip A. Philip

“Pancreatic cancer is notoriously challenging to treat and long overdue for a new approach,” Philip A. Philip, MD, PhD, FRCP, professor of oncology at Barbara Ann Karmanos Cancer Institute at Wayne State University and a medical adviser to Rafael Pharmaceuticals, said in the release. “We have remained hopeful throughout our pancreatic cancer trials and, now with fast track designation, our optimism is further fueled. We believe with this designation, cancer metabolism is truly being propelled forward, with devimistat at the helm.”

The FDA previously granted orphan drug designation to devimistat for treatment of pancreatic cancer, AML, myelodysplastic syndrome, peripheral T-cell lymphoma, Burkitt lymphoma and soft tissue sarcoma.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.