Onureg Approved to Treat Acute Myeloid Leukemia

July 24, 2020 – The U.S. FDA has approved Onureg® (azacitidine) tablets, manufactured by Bristol-Myers Squibb, to provide continued treatment for adults diagnosed with acute myeloid leukemia (AML) who have achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. Onureg is molecularly identical to Vidaza® (azacytidine – Bristol-Myers Squibb), a well-established FDA- approved injection treatment for AML.

An estimated 20,000 new cases of AML will be diagnosed in the United States in 2020, while approximately 11,180 people are expected to die of the disease. AML occurs when abnormal cells in the blood marrow reproduce rapidly, interfering with normal production of red blood cells, white blood cells, and platelets. The cancer is aggressive, and the duration of response to treatment can be brief, leaving patients in need of additional treatment options following initial therapy.

In a clinical study, Onureg delivered significant improvements in overall survival compared to placebo. The median overall survival time was more than two years with Onureg, versus 14.8 months with placebo. Recommended dosing is one 300mg tablet taken by mouth once daily for the first 14 days of each 28-day cycle until disease progression or unacceptable toxicity occur. An antiemetic (to prevent nausea and vomiting) should be taken before each dose for at least the first two cycles.

Launch and pricing plans are not yet available.