Bioenvision Files With EMeA For Label Extension Of Evoltra(R)

NEW YORK--(BUSINESS WIRE)--Bioenvision, Inc. (NasdaqGM:BIVN) today announced it has filed with the European Medicines Agency (EMeA) to expand the Evoltra®(clofarabine) label to include the treatment of acute myeloid leukemia (AML) in patients who are = 65-years-old and have one or more of the following: adverse cytogenetics, secondary AML, aged = 70 years, or have = 1 significant comorbidity. Evoltra® is currently approved in Europe to treat pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) and where there is no other treatment option anticipated to result in a durable response.

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