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Onureg FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved September 1, 2020)
Brand name: Onureg
Generic name: azacitidine
Dosage form: Tablets
Company: Bristol-Myers Squibb Company
Treatment for: Acute Myeloid Leukemia

Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the continued treatment of adult patients with acute myeloid leukemia.

  • Onureg is indicated for use in 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 is an oral tablet formulation of azacitidine, which was first approved under the brand name Vidaza (azacitidine for injectable suspension) for the treatment of myelodysplastic syndromes in 2004.
  • Onureg cannot be substituted for intravenous or subcutaneous azacitidine as the indications and dosing regimens differ between the oral and injectable formulations.
  • Onureg is administered orally once daily on Days 1 through 14 of each 28-day treatment cycle. An antiemetic is administered 30 minutes prior to each dose for at least the first 2 cycles to prevent nausea and vomiting.
  • Common adverse reactions (≥ 10%) include nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, and pain in extremities.

Development Timeline for Onureg

DateArticle
Sep  1, 2020Approval  FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
May  1, 2020U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia
Sep 12, 2019Celgene Announces Phase 3 QUAZAR® AML-001 Study of CC-486 as Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Met Primary and Key Secondary Endpoints

Further information

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