Pharmion Corporation has withdrawn its Marketing Authorization Application (MAA) in Europe for Vidaza (azacitidine for injectable suspension).

The company confirmed that the European regulatory authorities will require additional data in order to gain marketing approval for Vidaza in Europe and Pharmion intends to incorporate data from the company's ongoing survival trial into the MAA.

According to the company release, Pharmion is currently sponsoring a study of 354 high-risk myelodysplastic syndromes (MDS) patients comparing Vidaza to best supportive care (BSC) with or without low-dose chemotherapy, with overall survival as the primary endpoint of the study. Secondary endpoints in the trial include time to relapse after a partial or complete response, time to acute myeloid leukaemia (AML) progression as well as haematologic response and improvement.

This is the largest study ever conducted in MDS, and if successful, would be the first prospectively designed trial to demonstrate a survival advantage in patients with high-risk MDS. Based on current enrolment trends, the company anticipates that enrolment will be complete in early 2006. The company is assessing the possibility of submitting data from an interim analysis of the survival study, which Pharmion anticipates could occur as early as mid-2006.