- MAA submission based on data from largest Phase 3 study conducted in MDS
- Vidaza therapy confers highly significant 9.4 month median overall
survival advantage compared to conventional care regimens - Two year overall survival rate of 50.8% for Vidaza compared to 26.2% for
conventional care regimens
BOULDER, Colo., Jan. 14 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) today announced the submission of a MAA with the European Medicines Agency (EMEA) for Vidaza(R) (azacitidine for injection) in the treatment of patients with higher-risk MDS in the European Union (EU).
"We are pleased to submit this application to the EMEA, given the highly compelling data for Vidaza in the treatment of MDS," said Patrick J. Mahaffy, Pharmion's president and chief executive officer. "Vidaza is the only hypomethylating agent, and, in fact, the only drug to have shown an improvement in overall survival in this indication, and we believe it will become the standard of care throughout Europe for higher-risk MDS."
"Our study results presented late last year at the American Society of Hematology meeting confirm that Vidaza should be considered first-line therapy for patients with higher-risk MDS," said Pierre Fenaux, M.D., Professor of Hematology at the University of Paris, and Head, Department of Clinical Hematology, Hopital Avicenne, France, and principal investigator of the Phase 3 study. "Overall survival is the gold standard by which clinical benefit should be measured for patients, and these data demonstrate the tremendous benefit that Vidaza can provide these patients; this represents a significant advance in the treatment of MDS patients."
Vidaza has been designated as
|SOURCE Pharmion Corporation|
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