Bristol Myers Squibb Receives Positive CHMP Opinion for Onureg® for Adults with Acute Myeloid Leukemia in First Remission

Bristol Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Onureg® (azacitidine tablets; CC-486) 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).

The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, Onureg will be the first and only once daily frontline oral maintenance therapy to demonstrate significant overall survival in patients with a broad range of AML subtypes in first remission.

The CHMP adopted a positive opinion 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.

“Maintenance therapy options for acute myeloid leukemia that prolong overall survival have been urgently needed in Europe, especially oral options that can be taken at home. While many patients with acute myeloid leukemia achieve remission with induction therapy, responses to treatment may be of short duration and the risk of relapse remains high, especially for patients who are not eligible for stem cell transplant,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “We look forward to the European Commission’s decision and to making Onureg available to appropriate patients, building on our commitment to deliver innovative therapies that improve long-term outcomes for patients.”

The EC is expected to deliver its final decision within 67 days of receipt of the CHMP opinion. The decision will be applicable to all EU member states and Iceland, Norway 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. 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.