FDA approves Onureg for AML

The US Food and Drug Administration (FDA) has approved Onureg (azacitidine 300mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML), US pharma major Bristol Myers Squibb (NYSE: BMY) announced yesterday

The positive news follows a disappointment for BMS last month for its drug Idhifa (enasidenib), which failed in a Phase III IDHENTIFY trial in relapsed or refractory acute myeloid leukemia (R/R AML).

The oral azacitidine (CC-486) formulation was developed by Celgene, the $74 billion acquisition of which BMS completed late last year.