Devimistat Receives FDA Fast Track Designation for AML

The FDA has granted fast track designation to devimistat for the treatment of acute myeloid leukemia (AML), clearing its manufacturer, Rafael Pharmaceuticals, to begin the phase III ARMADA 2000 trial.

Devimistat is designed to target enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells, increasing their sensitivity to chemotherapies and allowing for effective treatment with lower doses of toxic drugs.

The agent has previously been granted orphan drug designation for the treatment of pancreatic cancer, AML, myelodysplastic syndromes, peripheral T-cell lymphoma, Burkitt lymphoma, and soft tissue sarcoma.

Source: Rafael Pharmaceuticals press release, December 15, 2020.