Celgene's VIDAZA Receives Positive CHMP Opinion as New Treatment for Elderly Patients with Acute Myeloid Leukaemia

Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation

today announced that that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) 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 >30% myeloblasts according to the WHO classification; previously, the indication covered AML patients with <30% blasts. Myeloblasts are white cells in the bone marrow; in AML, their functioning is disrupted and results in numerous non-functioning white