Oral Vidaza is an orally available formulation of Vidaza (azacitidine; Celgene/Nippon Shinyaku), a small molecule cytidine nucleoside analog that exerts its anti-cancer activity through direct cytotoxicity as well as through DNA hypomethylation. Intravenous Vidaza is approved for use in the EU to treat newly diagnosed AML patients over the age of 65 years who are not eligible for hematopoietic stem cell transplantation (HSCT). Vidaza is not approved for the treatment of AML in the US, but is available on the US market to treat patients with myelodysplastic syndrome (MDS); since patients lie on a continuum between MDS and AML, intravenous Vidaza is already used off-label for some AML patients. Due to the short half-life of Vidaza, it is believed that chronic drug exposure is required for patients to experience the maximum therapeutic effect. Therefore, an oral formulation would not only be more convenient for the patient, but could also increase the efficacy of the drug by allowing a more optimal dosing schedule.
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