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news.Genzyme has announced the withdrawal of the European application to extend the Evoltra product label to include the treatment of elderly patients with acute myeloid leukemia.
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In a letter to the European Medicines Agency (EMEA) on behalf of Bioenvision, Genzyme states that the withdrawal is based on the EMEA’s Committee for Medicinal Products for Human Use (CHMP) assessment that the data from the BIOV121 study are not sufficient to support a recommendation for market approval at this time. Bioenvision is now a wholly-owned subsidiary of Genzyme.
Mark Enyedy, president of Genzyme Oncology, a business unit of Genzyme, said: “We have engaged in a positive dialogue with the rapporteurs regarding the requirements for approval and will develop a new submission to include data from one or more ongoing clinical studies of clofarabine in this patient population for submission possibly as early as the fourth quarter of this year.”