- The European Commission approves an expanded label for Celgene's (NASDAQ:CELG) VIDAZA (azacitidine for injection) to now include adult patients aged 65 years and older with acute myeloid leukemia (AML) who are not eligible for hematopoietic stem cell transplantation (HSCT). Elderly AML patients typically have poor prognoses.
- The labeling has also been updated to include AML patients with greater than 30% myeloblasts according to the WHO classification. Previously, VIDAZA was approved for AML patients with less than 30% myeloblasts (white blood cells in the bone marrow). In AML, the function of myeloblasts is disrupted. The non-functioning cells can potentially interfere with the body's ability to fight infections and can lead to anemia and hemorrhages.
- VIDAZA is cleared in the EU for the treatment of certain myelodysplastic syndromes, chronic myelomonocytic leukemia and AML.
- VIDAZA is not approved in the U.S. for AML.