Genzyme withdraws Evoltra label extension

US biotechnology major Genzyme has withdrawn a European application to extend the product label for Evoltra (clofarabine) to include the treatment of elderly patients with acute myeloid leukemia. This application and the data on which it was based were filed by the drug's originator Bioenvision before it was acquired by Genzyme last year for $345.0 million (Marketletter June 4, 2007).

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. Mark Enyedy, president of Genzyme Oncology, said this decision was as expected. "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," he noted. In the USA, Genzyme has completed enrollment for a pivotal study in previously-untreated, older adult patients with AML who are unlikely to benefit from standard intensive induction chemotherapy. Data from the CLASSIC II trial are expected to further support the label expansion.