The drug is specifically indicated for pediatric patients who have relapsed or are refractory to at least two prior regimens.
The positive opinion must now be converted into a marketing authorization by the European Commission, a process that is expected to take three months, at which time Bioenvision will launch Evoltra throughout Europe.
Evoltra has already been granted orphan drug designation, providing marketing exclusivity for 10 years in Europe following marketing authorization.
“Evoltra is the first new drug for children with multiple relapsed or refractory leukemia to receive a positive opinion in Europe in more than a decade. It offers a genuine hope of response and disease free survival for this patient group,” said Hugh Griffith, Bioenvision’s CEO.
Bioenvision is also developing Evoltra for the treatment of adult acute myeloid leukemia (AML) as first-line therapy. The company has completed enrollment of its phase II clinical trial for the treatment of adult AML in elderly patients unfit for intensive chemotherapy and expects to file a marketing authorization application in mid 2006 for the company’s first label-extension for the drug.