The Food and Drug Administration (FDA) has accepted Celgene Corp.'s new drug application for Enasidenib, a treatment for patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 mutation.
Enasidenib is an investigational drug that has not been approved for any use in any country, according to Calgene announcement.
Celgene is in partnership with Agios Pharmaceuticals in developing the drug for FDA approval.
The FDA also granted priority review and has given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30.
"We accelerated this application — submitting the NDA (New Drug Application) just three years after the first patient was treated in the Enasidenib pivotal investigational trial — because we believe that there is a significant unmet need for people with relapsed or refractory AML," Michael Pehl, president of hematology/oncology for Celgene, said in the announcement.
"The acceptance of the Enasidenib NDA is a significant milestone in what we hope will be a new era of molecularly targeted therapies for patients with this devastating disease," Pehl said.
