publication date: Sep. 4, 2020

Drugs & Targets

Onureg oral therapy receives FDA approval for continued treatment for adults in first remission with AML

FDA has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission, or CR with incomplete blood count recovery, following intensive induction chemotherapy and who are not able to complete intensive curative therapy.

Onureg is sponsored by Bristol Myers Squibb.

The approval is based on results from the pivotal phase III QUAZAR AML-001 study in which treatment with Onureg resulted in a statistically significant and clinically meaningful improvement in overall survival, the study’s primary endpoint, of nearly 10 months compared to placebo.

Median OS from time of randomization was greater than two years (24.7 months; 95% Confidence Interval [CI]: 18.7 to 30.5) among patients who received Onureg compared to 14.8 months (95% CI: 11.7 to 17.6) among patients receiving placebo (Hazard Ratio [HR]: 0.69, 95% CI: 0.55 to 0.86; p=0.0009). Onureg was continued until disease progression or unacceptable toxicity. Onureg has warnings and precautions for risks of substitution with other azacitidine products, myelosuppression, increased early mortality in patients with myelodysplastic syndromes (MDS) and embryo-fetal toxicity.

“Continued treatment with Onureg demonstrated an overall survival benefit in adults with AML who had achieved first complete remission in the QUAZAR® AML-001 study and, notably, it has the potential to do this in a convenient manner, given its once daily oral formulation,” said Andrew Wei, QUAZAR AML-001 lead investigator, Alfred Hospital and Monash University, Melbourne, Australia, said in a statement. “This approval should help establish continued treatment with Onureg as a standard component of AML therapy for adults who achieved first … Continue reading Onureg oral therapy receives FDA approval for continued treatment for adults in first remission with AML

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