Bioenvision receives EU approval for leukemia drug

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

Specifically, Evoltra is approved to treat acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or failed to respond to previous treatments. The licensed indication includes patients who were less than 21 at the time of initial diagnosis of their leukemia.

Although the first-line treatment of children with leukemia is generally successful, patients with multiple relapsed or refractory leukemia have a low response rate and a very poor prognosis. The average survival rate is between 8 and10 weeks.

In the pivotal clinical study 30% of children who responded to Evoltra survived 66.6 weeks. In addition to extending the life of children who responded to treatment, Bioenvision’s drug allowed the young patients the opportunity to receive a bone marrow transplant, which offers the chance of a potential cure.

“The launch of Evoltra into the European market is the cornerstone of Bioenvision’s commercial strategy and enables Bioenvision to build a successful Evoltra franchise not only throughout Europe but also in other important world markets,” said Dr Christopher Wood, Bioenvision’s chairman and CEO.