FDA approves Onureg for AML in first remission
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The FDA approved a new once-daily oral therapy for treatment of certain patients with acute myeloid leukemia.
Azacitidine tablets (Onureg, Bristol Myers Squibb) are indicated for continued treatment of adults with AML who achieved first complete remission or complete remission with incomplete blood count recovery after intensive induction chemotherapy, and who are not able to complete intensive curative therapy, such as hematopoietic stem cell transplant.
The FDA based the approval on results of the randomized phase 3 QUAZAR AML-001 study, which included 472 adults aged 55 years or older with AML. All patients were within 4 months of achieving first complete remission or complete remission with incomplete blood count recovery after induction chemotherapy, and they were not candidates for HSCT at the time of screening.
Researchers randomly assigned 238 patients to azacitidine 300 mg tablets once daily for 14 days of a 28-day cycle, plus best supportive care. The other 234 patients received placebo plus best supportive care.
Median duration of treatment was 12 cycles (range, 1-82) in the experimental group and six cycles (range, 1-76) in the placebo group.
As Healio previously reported, results showed patients assigned azacitidine tablets achieved significantly prolonged OS (24.7 months vs. 14.8 months; HR = 0.69; 95% CI, 0.55-0.86).
Fifteen percent of patients in the experimental treatment group experienced serious adverse events, the most common of which were pneumonia (8%) and febrile neutropenia (7%). One patient died of sepsis.
The most common adverse reactions that occurred more frequently in the experimental group than the placebo group included nausea (65% vs. 24%), vomiting (60% vs. 10%), diarrhea (50% vs. 21%), fatigue (44% vs. 25%), constipation (39% vs. 24%) and pneumonia (27% vs. 17%).
Eight percent of patients assigned the experimental therapy discontinued treatment due to adverse events.
The FDA previously granted priority review to this new drug application.
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