Five-day Vidaza dosing shows efficacy
Azacitidine study shows five-day dosing schedule is efficacious
Preliminary analysis of a Phase II clinical trial evaluating five-day dosing schedules for azacitidine (Vidaza, Pharmion) has shown efficacy and safety that are similar to the drug?s currently recommended seven-day schedule. The data, which were presented at the 49th Annual Meeting and Exposition of the American Society of Hematology, suggest that a five-day schedule is as effective at achieving red blood cell transfusion independence in patients with Myelodysplastic Syndromes (MDS). According to Pharmion, a five-day schedule would be more convenient for patients and eliminate the need for weekend dosing. Azacitidine, a demethylating agent, was approved in 2004 as the first drug for the treatment of all five subtypes of MDS.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
