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Positive data for azacitidine in MDS

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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).

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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

 






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