Bioenvision (BIVN) Provides Evoltra® (clofarabine) Regulatory Update
8/20/2007 4:29:27 PM
New York, NY (August 16, 2007) – Bioenvision, Inc. (Nasdaq:BIVN) today announced an update on the status of its Marketing Authorization Application to the European Medicines Evaluation Agency (EMeA) to include a new indication for Evoltra® (clofarabine) for the treatment of acute myeloid leukaemia (AML) in elderly patients who have one or more of the following: adverse cytogenetics, secondary AML, = 70 years old or significant co-morbidities and are therefore not considered suitable for intensive chemotherapy. Evoltra is currently approved in Europe 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.
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