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www.fdanews.com/articles/198847-bristol-myers-squibbs-onureg-approved-for-acute-myeloid-leukemia
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Bristol Myers Squibb’s Onureg Approved for Acute Myeloid Leukemia

September 3, 2020

The FDA has approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets) for adults with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following chemotherapy and cannot complete intensive curative therapy.

The approval was based on a phase 3 clinical trial in which Onureg improved overall survival by nearly 10 months compared to a placebo in patients with acute myeloid leukemia in first remission. Median overall survival was 24.7 months with Onureg compared to 14.8 months among those on placebo.

Onureg is the first FDA-approved continued treatment for AML patients in remission. It was granted Priority Review and Orphan Drug designations. 

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