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New Drugs Approved In September

Onureg
Onureg

The FDA green-lighted Onureg (azacitidine), developed by Bristol-Myers Squibb Company (BMY) on September 1, 2020.

Onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

Onureg, the first and only FDA-approved continued AML therapy for patients in remission, is an oral hypomethylating agent that incorporates into DNA and RNA.

The drug has warnings for risks of neutropenia, thrombocytopenia, increased early mortality in patients with Myelodysplastic Syndromes (MDS), and embryo-fetal toxicity.

Onureg is under review by the European Medicines Agency.