Celgene Corp. and Agios Pharmaceuticals Inc. recently received U.S. Food and Drug Administration approval for IDHIFA as a treatment for adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.
"The FDA approval of IDHIFA provides the first-ever treatment option for patients living with relapsed or refractory AML and an IDH2 mutation," Celgene CEO Mark Alles said in a statement. "We appreciate the FDA's efforts to expedite the availability of IDHIFA for patients with this devastating disease weeks ahead of the PDUFA date."
Alles noted the milestone showcases Celgene’s unique research model and illustrates how collaboration can help the lives of patients across the globe.
"The FDA approval of IDHIFA just four years after entering the clinic is the first of what we expect to be multiple first-in-class precision medicines for patients with cancer and rare genetic diseases from our productive discovery engine," Agios CEO Dr. David Schenkein said.