EU approves Onureg for patients with acute myeloid leukemia
pharmafile | June 21, 2021 | News story | Sales and Marketing |
The European Commission has approved Onureg as frontline oral maintenance therapy for patients with a broad range of acute myeloid leukemia (AML) subtypes.
AML is one of the most common acute leukemias in adults with a 17% five-year survival rate in Europe.
Noah Berkowitz, Senior Vice President, Hematology Development, Bristol Myers Squibb, said: “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.
“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.”
Andrew Wei, QUAZAR AML-001 lead investigator, Alfred Hospital and Monash University, Melbourne, Australia, said: “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.
“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 approval of Onureg was based on results from the QUAZAR AML-001 study, a Phase III, randomised, 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.
AML is one of the most common acute leukemias in adults. The worldwide incidence of AML has been estimated at more than 350,000 cases, and the estimated 5-year survival rate for AML in Europe is 17%. AML is characterized by the rapid growth of abnormal cells in the bone marrow and as such interferes with normal blood cell production and function.
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