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www.fdanews.com/articles/173915-ec-expands-approval-of-celgenes-acute-myeloid-leukemia-drug-vidaza

EC Expands Approval of Celgene’s Acute Myeloid Leukemia Drug Vidaza

November 5, 2015

The European Commission has granted an expanded approval to Celgene International Sàrl’s injectable acute myeloid leukemia drug Vidaza (azacitidine) for patients 65 and older who are not eligible for stem cell transplants.

The new indication covers patients who have greater than 30 percent myeloblasts. Previously, only AML patients with less than 30 percent myeloblasts were covered by the indication.

The EC based its decision on a global study for which Vidaza demonstrated a median overall survival of 10.4 months, compared with 6.5 months for patients receiving conventional treatment regimens. Vidaza also topped conventional treatments in one-year survival rate, 46.5 percent to 34.2 percent.