Onureg is the first and only once-daily, frontline oral maintenance therapy in the European Union (EU) for patients with a broad range of acute myeloid leukemia (AML) subtypes

In the pivotal QUAZAR® AML-001 study, Onureg significantly improved overall survival and relapse-free survival in patients with AML

PRINCETON, N.J.--(BUSINESS WIRE)-- 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).

About QUAZAR® AML-001

QUAZAR® AML-001, is a Phase 3, international, randomized, double-blind study. 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) within four months (+/- 7 days) before randomization, and were not candidates for HSCT at the time of screening. The study enrolled 472 patients, randomized 1:1 to receive either Onureg 300 mg (N=238) or placebo (N=234) orally, once daily, for 14 days of a 28-day cycle, plus best supportive care and results were published in the New England Journal of Medicine in December 2020.*3,4

Median OS, the primary endpoint, from time of randomization was greater than two years (24.7 months; 95% CI: 18.7 to 30.5) in the Onureg arm compared to 14.8 months for placebo (HR: 0.69, 95% CI: 0.55 to 0.86; p=0.0009). The median duration of treatment was 12 cycles (1 to 82) for Onureg and 6 cycles with placebo (1 to 76). Median relapse-free survival was also significantly longer with Onureg than with placebo (10.2 months and 4.8 months, respectively; p