EC nod for Onureg as maintenance oral therapy for adults with AML

21 June 2021

The European Commission (EC) has granted full Marketing Authorization for Onureg (azacitidine tablets; CC-486), US pharma major Bristol Myers Squibb (NYSE: BMY) announced on Friday.

The drug is cleared as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).

Onureg is the first and only once-daily, frontline oral maintenance therapy to demonstrate significant overall survival and show a relapse-free survival benefit in patients with a broad range of AML subtypes. The EC approval follows a positive recommendation from the European Medicines Agency’s advisory committee, the CHMP, in April this year.

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