CHMP grants expended indication for Vidaza (azacitidine for injection) for older patients with AML not eligible for stem cell transplantation- Celgene

Celgene International announced that that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for an expanded indication of Vidaza (azacitidine for injection) for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplantation (HSCT). The expanded indication now covers patients who have more than 30% myeloblasts according to the WHO classification; previously, the indication covered AML patients with less than 30%. Myeloblasts are white cells in the bone marrow; in AML, their functioning is disrupted and results in numerous non-functioning white cells, which can potentially interfere with the body's ability to control infections and can lead to anaemia and haemorrhage.

For many patients, AML is typically associated with a poor prognosis and deteriorating quality of life, particularly for those patients who cannot tolerate curative therapies like HSCT. In Europe, more than 14,000 people suffer from AML, and most of these patients will die within less than 1 year. As an acute leukaemia, AML progresses rapidly and is typically fatal within months if HSCT is not an option. In elderly patients, overall survival with AML has not improved in more than 40 years, and there is a clear need for treatments that can support this patient population.