Bristol-Myers Squibb (BMY) Receives European Commission Approval for Onureg as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia

June 18, 2021 9:35 AM EDT

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Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted full Marketing Authorization for Onureg® (azacitidine tablets) as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). Onureg is the first and only once-daily, frontline oral maintenance therapy to demonstrate significant overall survival and show a relapse-free survival benefit in patients with a broad range of AML subtypes.

The centralized Marketing Authorization approves use of Onureg in all EU member states, as well as Norway, Iceland and Liechtenstein.* Onureg is approved in the United States for the continued treatment of adult patients with AML who achieved first CR or CRi following intensive induction chemotherapy and who are not able to complete intensive curative therapy.1 In Canada, Onureg is approved as a maintenance therapy for adult patients with AML who achieved CR or CRi following induction therapy with or without consolidation treatment, and who are not eligible for HSCT.2

“An unmet need exists for maintenance therapy options for acute myeloid leukemia in the European Union, given responses to induction therapy may be of short duration and the risk of relapse is high, especially for patients not eligible for stem cell transplant,” said Andrew Wei, MBBS, Ph.D., QUAZAR® AML-001 lead investigator, Alfred Hospital and Monash University, Melbourne, Australia. “The approval of Onureg by the European Commission has the potential to clinically benefit and change the treatment paradigm of patients with acute myeloid leukemia, across a range of subtypes.”

The EC approval of Onureg was based on results from the QUAZAR® AML-001 study, a Phase 3, international, randomized, double-blind trial. Eligible patients were ages 55 years or older, had newly diagnosed AML, intermediate or poor cytogenetics, had achieved first CR or CRi following intensive induction chemotherapy with or without consolidation treatment (per investigator preference prior to study entry), and were not candidates for HSCT at the time of screening.3

“Today’s approval of Onureg represents a significant advance for patients in the European Union living with acute myeloid leukemia, who have remained in urgent need of maintenance therapies for this aggressive blood cancer,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “We are committed to helping to improve long-term outcomes and greatly extending survival for patients with hard-to-treat diseases, as we work collaboratively with European Union member states to make Onureg available to eligible patients as quickly as possible.”

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).

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