SciQuest.org

The Myelodysplastic Syndromes (MDS) Foundation supports the decision by the U.S. Food & Drug Administration (FDA) to extend the label for VIDAZA (azacitidine) to include data from the AZA-001 clinical trial. Results from the trial found that azacitidine is the only agent which has been shown to extend survival in MDS patients.

Data from the AZA-001 trial was recently presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting and found that azacitidine nearly doubled the two-year survival rate for higher-risk MDS patients compared to conventional care regimens (CCR) with a mean survival of 24.5 months compared to 15 months for patients who received CCR.

"We are extremely encouraged by the results of the AZA-001 trial which for the first time showed that survival could be extended for patients with higher-risk MDS," said Kathy Heptinstall, Operating Director of the Myelodysplastic Syndromes Foundation, "Roughly 30 percent of patients diagnosed with MDS will progress to acute myeloid leukemia (AML), but treatment with VIDAZA significantly delays this progression. VIDAZA not only has great survival data in MDS, but can also prevent progression to AML."