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FDA approval of CC-486 for the treatment of adults with AML in first remission

Sep 3, 2020
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On September 1, 2020, the U.S. Food and Drug Administration (FDA) approved the use of CC-486, oral azacitidine, for the maintenance of adult patients with acute myeloid leukemia (AML) in first remission after intensive induction chemotherapy, who are not able to complete intensive curative therapy. This includes patients in complete remission with incomplete hematological recovery.1

The approval was based on the results of the phase III QUAZAR AML-001 trial (previously reported on the AML Hub), which showed a clinically meaningful improvement in overall survival for patients > 55 years of age, treated with CC-486 plus best supportive care, compared to placebo (24.7 vs 14.8 months, respectively; p = 0.0009). 1

The convenient oral administration of this drug once daily makes it more appealing in this current climate, however, there are warnings that CC-486 should not be substituted for intravenous or subcutaneous azacitidine due to significant differences in pharmacokinetic properties.1

The FDA approval could see treatment with CC-486 become a standard component of AML therapy for adults in first complete remission who cannot proceed to intensive curative therapy.

  1. Bristol Myers Squibb. U.S. Food and Drug Administration approves Onureg® (azacitidine tablets), a new oral therapy, as continued treatment for adults in first remission with acute myeloid leukemia. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-onureg-azacitidine-ta. Published Sep 1, 2020. Accessed Sep 2, 2020.

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