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EMA approves Onureg for acute myeloid leukemia.- BMS

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Published:20th Jun 2021
Bristol Myers Squibb 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 EC approval of Onureg was based on results from the QUAZAR AML-001 study, a Phase III, 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.

Condition: Acute Myelogeous Leukemia (AML)
Type: drug

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