BIOENVISION GETS EUROPEAN APPROVAL FOR EVOLTRA

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Bioenvision has reported that the European Commission has granted marketing authorization for Evoltra (clofarabine) for the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.

Evoltra can now be marketed throughout all 25 member states of the EU. Evoltra has been granted orphan-drug designation, providing marketing exclusivity for 10 years in Europe following this marketing authorization.