FDA Designates Fast Track for Pancreatic Cancer Drug


Devimistat is designed to be used in conjunction with other drugs to make cancer cells more sensitive to treatment.

The FDA has granted Fast Track designation to devimistat (CPI-613, Rafael Pharmaceuticals) for the treatment of metastatic pancreatic cancer.

Metastatic pancreatic cancer is considered difficult to treat. A new approach is needed for the treatment of the disease, according to Rafeal officals.

Devimistat is meant to target the mitochondrial tricarboxylic acid cycle. This process occurs exclusively in cancer cells and is essential to tumor cell survival and multiplication. Devimistat increases the sensitivity of cancer cells to a range of chemotherapeutic agents. This action potentially allows for devimistat to be combined with lower doses of usually toxic drugs to be more effective while also lowering the risk of severe adverse effects for patients.

“Receiving Fast Track designation is a significant milestone in our fight against pancreatic cancer,” said Sanjeev Luther, president and CEO of Rafael, in a prepared statement. “This designation further stresses the severe unmet need in treatment options for this aggressive and devastating disease.”

The FDA has granted Rafeal the permission to begin phase 3 clinical trials in patients with pancreatic cancer and acute myeloid leukemia. Additionally, devimistat has been granted orphan drug status for the treatment of pancreatic cancer, acute myeloid leukemia, peripheral T-cell lymphoma, myelodysplastic syndrome, Burkitt’s lymphoma, and soft tissue sarcoma.

At this time, devimistat has not been approved by the FDA.


Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer [news release] Cranbury, NJ; November 10, 2020: Rafael. Accessed November 11, 2020. http://www.globenewswire.com/news-release/2020/11/10/2123878/0/en/Rafael-Pharmaceuticals-Receives-FDA-Fast-Track-Designation-for-CPI-613-devimistat-for-the-Treatment-of-Pancreatic-Cancer.html.

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