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EMEA delays Evoltra AML decision


The manufacturer of Evoltra (clofarabine) has been given more time to provide information relating to a request for the drug to be authorised for treating acute myeloid leukaemia (AML).

Bioenvision is seeking approval from the European Medicines Agency (EMEA) for the drug to be made available to elderly patients with AML who are not considered suitable for intensive chemotherapy treatment.

In May, the EMEA’s committee for medicinal products for human use asked Bioenvision to provide additional information about the drug, to help it make its judgement.

And it has now agreed that the company does not have to supply the information until 16 November.

The decision has been made to allow the firm to make a more comprehensive submission and also include interim data from an ongoing AML study, which is sponsored by the National Cancer Research Institute.

Bioenvision said it anticipates the EMEA will provide an assessment report in December once it has received the report, and will make a decision on whether to grant the request or ask for further information in January next year.

Evoltra is currently approved in Europe for the treatment of acute lymphoblastic leukaemia (ALL) in some paediatric patients.

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