Acute myelogenous leukemia (AML) is one of the most common forms of acute leukemia in adults. The incidence of the disease is estimated at more than 350,000 cases worldwide, while the estimated five-year survival rate for AML in Europe is close to 17%. AML is characterized by the rapid proliferation of abnormal cells in the bone marrow, leading to abnormal production and function of blood cells. Due to the reduced production of red blood cells, platelets and white blood cells, patients may experience anemia, bleeding and infections. AML is a heterogeneous disease that is associated with a variety of genetic mutations and, if not treated early, can progress rapidly and lead to the death of the patient.
Patients' response to treatment may be short-lived. This means that after the initial response to chemotherapy, about half experience relapse within a year, highlighting the significant unmet need for maintenance treatments that prolong overall survival.
Approval of a new treatment for acute myelogenous leukemia
Bristol Myers Squibb recently announced that the European Commission has granted full marketing authorization for azacitidine tablets as maintenance therapy to adult patients with acute myeloid leukemia (AML) who have achieved complete remission (CR) or complete remission with incomplete hematopoietic ) after attack treatment in combination with or without stabilization treatment. These patients are not candidates for hematopoietic stem cell (HSCT) transplantation or choose not to have a transplant. Azacitidine in tablets is the first initial maintenance treatment, given orally once daily, which demonstrates on the one hand significant overall survival and on the other hand benefit of disease-free survival in patients suffering from different subtypes of AML.
“The need for maintenance treatment options for acute myelogenous leukemia remains unresolved in the European Union, given that the response to attack therapy may be short-lived and the risk of recurrence is high, especially for patients who are not considered suitable for stem cell transplantation. Said Andrew Wei, MBBS, Ph.D., lead researcher on the QUAZAR® AML-001 study at Alfred Hospital and Monash University in Melbourne, Australia. “The approval of azacitidine tablets by the European Commission has the potential to offer clinical benefit and change the therapeutic pattern for patients with different subtypes of the disease.”
The approval of azacitidine tablets by the European Commission was based on results from the QUAZAR® AML-001 study, an international, randomized, double-blind Phase 3 study. had intermediate or high-risk cytogenetic analysis findings, had achieved first complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after intensive onset chemotherapy in combination with or without stabilization treatment before the study ) and were not candidates for hematopoietic stem cell (HSCT) transplantation during screening.
source: Capital.gr
