The U.S. Food and Drug Administration has granted Celgene Corporation’s Vidaza® (azacitidine) an expanded indication that includes higher-risk myelodysplastic syndrome patients. Vidaza is already approved for five MDS subtypes, according to the French American British classification; these subtypes include refractory anemia or refractory anemia with ringed sideroblasts if accompanied by neutropenia or thrombocytopenia or requiring transfusions, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
Vidaza is a demethylation agent. Its expanded approval is based on improved survival results in the AZA-001 trial.
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