Pharmion Corporation has announced data from its phase III trial of azacitidine (Vidaza® injection) vs conventional care regimens (CCR) in the treatment of 358 patients with higher-risk myelodysplastic syndromes (MDS).
The primary endpoint analysis showed that azacitidine was associated with a median survival of 24.4 months vs 15 months for the CCR group (hazard ratio 0.58; 95% CI 0.43–0.77; p= 0.0001).
Corresponding two-year survival rates were 50.8% vs 26.2% (p<0.0001). The survival benefits of azacitidine were reported to be consistent regardless of the CCR treatment option (best supportive care alone, low-dose cytarabine plus best supportive care or standard chemotherapy plus best supportive care).
The company expects to present the full study results at an upcoming medical meeting and based on these data, it intends to file a marketing authorisation application in the EU for treating higher-risk MDS before the end of 2007.
In May 2004 azacitidine became the first drug approved by the FDA for treating patients with MDS.
The drug is the first in a new class of drugs called demethylation agents, and was approved in the US for treatming all five MDS subtypes in low- and high-risk patients.
National Electronic Library for Medicines 3/8/2007