Pharmion Submits European Marketing Authorization Application (MAA) For Vidaza(R) In Patients With Higher Risk Myelodysplastic Syndromes (MDS)
"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 an Orphan Medicinal Product in the EU for the treatment of MDS, which, if approved, entitles the drug to ten years of market exclusivity for the approved indication. Vidaza has also been designated as an Orphan Medicinal Product in the EU for the treatment of acute myeloid leukemia (AML).
The application is based upon clinical data which includes the results from the Company's Phase 3 multi-center, international, randomized study of Vidaza(R) (azacitidine for injection) in the treatment of patients with higher-risk MDS. The primary objective of this Phase 3 trial was to demonstrate superiority in overall survival of Vidaza versus CCR. The study included 358 patients at sites in the U.S., Europe, and Australia. At baseline, approximately 90 percent of patients were considered to have higher- risk MDS, based on subsequent independent review of FAB subtypes or IPSS classification. Patients were assigned to treatment with Vidaza (N=179; 75 mg/m2/day SC for seven consecutive days every 28 days) or CCR. Patients assigned to CCR could receive either BSC alone (N=105), low-dose cytarabine (LDAC; N=49), or standard chemotherapy (Std Chemo; N=25). The median number of cycles for Vidaza was nine; the median number of cycles for the CCR arm was as follows: BSC seven cycles, LDAC 4.5 cycles and Std Chemo one cycle.
With a median follow-up of 21.1 months, Vidaza demonstrated a statistically significant overall survival advantage over CCR (24.4 months vs. 15 months; stratified log rank p=0.0001).The hazard ratio describing this treatment effect was 0.58 (95 percent confidence interval of 0.43 to 0.77). At two years, Vidaza demonstrated a two-fold advantage in overall survival over CCR (51 percent vs. 26 percent; log rank p
Pharmion Prezintã Europene autorizaþie de introducere pe piaþã Application (MAA) Pentru Vidaza (R), la pacienþii cu risc mai mare Myelodysplastic sindroame (MDS) - Pharmion Submits European Marketing Authorization Application (MAA) For Vidaza(R) In Patients With Higher Risk Myelodysplastic Syndromes (MDS) - articole medicale engleza - startsanatate