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.
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