Evoltra is currently approved in Europe to treat pediatric patients with relapsed or refractory acute lymphoblastic leukemia and where there is no other treatment option anticipated to result in a durable response.
The application is based on the results of several studies, including a phase II study in which elderly patients treated with Evoltra had a complete response rate of 44%.
“Many of the elderly patients with AML, especially those with poor prognostic factors, have few, if any, appropriate treatment options available,” said professor Christopher Wood, chairman and CEO of Bioenvision.
“Evoltra could offer a new treatment option for physicians and a new hope for this patient population.”
Bioenvision has conducted a phase I clinical study of Evoltra for the treatment of psoriasis and is planning further worldwide development of Evoltra in autoimmune diseases.