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FDA grants priority review to enasidenib for IDH2–mutant AML
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The FDA granted priority review to enasidenib for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 mutation, according to the drug’s manufacturer.
Enasidenib (AG-221/CC-90007; Celgene, Agios) is an oral targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2).
“Having received new drug application acceptance and priority review for enasidenib, we look forward to working with our partner Celgene and the FDA to advance a first-in-class therapy for relapsed or refractory AML with an IDH2 mutation,” David Schenkein, MD, CEO of Agios, said in a press release. “We hope that the continued adoption of molecular profiling and availability of new targeted therapies such as enasidenib will have a significant impact on patients living with AML.”
The new drug application included results from the single-arm phase 1/phase 2 AG221-C-001 study, designed to evaluate enasidenib in patients with advanced hematologic malignancies with IDH2 mutations.
The FDA is expected to make a decision on enasidenib by Aug. 30.
“We accelerated this application — submitting the new drug application just 3 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 a press release. “The acceptance of the enasidenib new drug application is a significant milestone in what we hope will be a new era of molecularly targeted therapies for patients with this devastating disease.”
Celgene also is evaluating enasidenib in the ongoing phase 3 IDHENTIFY trial, designed to compare the agent with conventional therapy in older patients with relapsed or refractory AML and an IDH2 mutation.