Bioenvision receives European approval for Evoltra for acute lymphoblastic leukemia

New York, May 31 - Bioenvision, Inc. said it has been given authorization to market Evoltra (clofarabine) for the treatment of acute lymphoblastic leukemia in Europe.

The permission covers pediatric patients aged less than 21 years at the time of initial diagnosis 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.

Marketing is now allowed throughout all 25 member states of the European Union. Evoltra was granted orphan drug designation, providing marketing exclusivity for 10 years following the authorization.

Bioenvision noted that the first-line treatment of children with leukemia is generally successful, but patients with multiple relapsed or refractory leukemia have a low response rate and a very poor prognosis, with a median survival of approximately eight to 10 weeks.

In the pivotal clinical study with Evoltra a median survival of 66.6 weeks was achieved in the 30% of children who responded to treatment with Evoltra.

In addition to extending the life of children who responded to treatment, Evoltra also gives these children the opportunity to receive a bone marrow transplant, which offers the chance of a potential cure, the New York-based company said.

"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 Christopher B. Wood, Bioenvision's chairman and chief executive officer, in a news release. He added "we have recruited and trained a dedicated, specialist oncology sales team who will market Evoltra in Europe and that team will be expanded as the market grows".

Bioenvision is also developing Evoltra for the treatment of adult acute myeloid leukemia as first-line therapy. It has completed enrollment of its phase 2 clinical trial for the treatment of adult acute myeloid leukemia in elderly patients unfit for intensive chemotherapy and expects to file a Marketing Authorization Application in 2006 for the first label extension for Evoltra.

In addition, Bioenvision is conducting late-stage preclinical development of Evoltra for the treatment of psoriasis and is planning further worldwide development of the drug in autoimmune diseases.

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