Ontuxizumab

FDA Grants Rafael Pharmaceuticals Orphan Drug Designation for CPI-613® (Devimistat) for Treatment of Biliary Cancer

Retrieved on: 
Tuesday, June 29, 2021

CRANBURY, N.J., June 29, 2021 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (Rafael or the Company), a leader in the growing field of cancer metabolism-based therapeutics, announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for CPI-613 (devimistat) for the treatment of biliary cancer.

Key Points: 
  • CRANBURY, N.J., June 29, 2021 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (Rafael or the Company), a leader in the growing field of cancer metabolism-based therapeutics, announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for CPI-613 (devimistat) for the treatment of biliary cancer.
  • Biliary cancer appears when cancer cells form in the bile ducts or gallbladder, an essential aspect of the gastrointestinal system.
  • The orphan drug designation for devimistat showcases the importance of discovering these new treatment options.
  • Devimistat has been granted orphan drug status by the FDA for the treatment of pancreatic cancer, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), Burkitts lymphoma, peripheral T-cell lymphomas, and soft tissue sarcoma, and now, biliary cancer.