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Bristol Myers Squibb Gets FDA Approval for Onureg Tablets

September 1, 2020

Bristol Myers Squibb said Tuesday the U.S. Food and Drug Administration has approved Onureg azacitidine 300 mg tablets, CC-486, for the continued treatment of adult patients with acute myeloid leukemia.

The pharmaceutical company said the approval is based on results from a Phase 3 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 with placebo.

Median overall survival from time of randomization was greater than two years, it said. 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 and embryo-fetal toxicity. Bristol Myers Squibb said that due to substantial differences in the pharmacokinetic parameters, Onureg shouldn’t be substituted for intravenous or subcutaneous azacitidine as it may result in a fatal adverse reaction.

The new drug application was granted priority review designation by the FDA, and a marketing authorization application for this indication was validated by the European Medicines Agency in May 2020.

The study enrolled 472 patients, randomized 1:1 to receive either Onureg 300 mg or placebo orally, once daily, for 14 days of a 28-day cycle, plus best supportive care.

Serious adverse reactions occurred in 15% of patients who received Onureg. The most common adverse reactions with Onureg versus placebo were nausea, vomiting, and diarrhea, the company said. Of patients who received Onureg, permanent discontinuation due to an adverse reaction occurred in 8% of patients.

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