FDA Clears Celgene’s Acute Myeloid Leukemia Drug
The FDA has granted regular approval to Celgene’s drug candidate for treatment of relapsed or refractory acute myeloid leukemia.
The drug, enasidenib, marks the first FDA approval for relapsed or refractory AML specifically with an isocitrate dehydrogenase-2 mutation. The agency based its approval on a multicenter clinical trial including 199 adult patients.
Adverse reactions included nausea, vomiting and decreased appetite, as well as differentiation syndrome. The prescribing information will include a boxed warning on the need for early intervention for differentiation syndrome.