Pharmaceutical company Pharmion has submitted a European Marketing Authorization Application (MAA) for Vidaza, for the treatment of patients with high risk MDS in the European Union (EU).
The MAA, submitted to the European Medicines Agency (EMEA), was based in part on an international Phase 3 trial of 358 mostly high-risk MDS patients in the U.S., Europe, and Australia. Treatment with Vidaza was compared with a conventional care regimen (CCR) and found to improve overall survival. Approval in Europe will expand the availability of Vidaza for high risk MDS patients.
Vidaza is a demethylation agent used to treat MDS/RA (refractory anemia), MDS/RARS (refractory anemia with ringed sideroblasts), MDS/RAEB (refractory anemia with excess blasts), MDS/RAEB-T (refractory anemia with excess blasts in transformation), and chronic myelomonocytic leukemia (CMMoL).
From Pharmion's
press release:
"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."
Intravenous (IV) administration of Vidaza (azacitidine) for treatment in the U.S. of all subtypes of MDS was
approved by the FDA in January 2007.