FDA expands Vidaza MDS approval

The FDA has expanded the approval of Vidaza (azacitidine injection, from Celgene) to include extended survival times in higher-risk myelodysplastic syndrome (MDS) patients. This approval was based on results from a Phase 3 trial that showed the median overall survivalfor patients treated with Vidaza was 24.5 months compared to 15 months for conventional care regimens (CCR). The two-year survival ratefor higher-risk MDS treated with Vidaza was 50.8% compared to 26.2% for CCR-treated patients.

Vidaza, a nucleoside metabolic inhibitor, is approved for the treatment of MDS patients, including those with refractory anemias and chronic myelomonocytic leukemia.

For more information call (908) 673-9000 or visit www.vidaza.com.