European approval for Celgene’s Vidaza in new indication of AML

The European Commission (EC) has approved Vidaza (azacitidine for injection) for the treatment of adult patients aged 65 years or older with acute myeloid leukemia (AML) who are not eligible for hematopoietic stem cell transplantation (HSCT).

The Vidaza Marketing Authorization, which was submitted Celgene Corp’s (Nasdaq: CELG) European subsidiary, has been updated to include this new indication in AML, covering patients who have >30% myeloblasts according to the WHO classification; previously, the indication covered AML patients with <30% blasts.

“Today’s announcement brings hope to patients with AML, particularly the elderly and more frail patients who cannot undergo intensive therapies such as stem cell transplantation,” said Hervé Dombret, chief of the Blood Disease Department (Leukemia Unit), University Hospital Saint-Louis, AP-HP, Paris, France. “Azacitidine has demonstrated a median overall survival of 10.4 months in these patients, which is a clinically relevant benefit and gives us a new treatment option in a previously underserved group of patients,” Dr Dombret added.