MabCampath nears EU approval for CLL
Schering AG's MabCampath (alemtuzumab) has been recommended for approvalby the European Union's Committee for Proprietary Medicinal Products for the treatment of chronic lymphocytic leukemia in patients who are no longer suitable for treatment with alkylating agents and fludarabine. Schering has developed MabCampath in collaboration with Millennium Pharmaceuticals and ILEX Partners.
Schering notes that the approval has been granted "under exceptional circumstances," and is conditional on a post-approval confirmatory study comparing the drug's safety and efficacy in CLL patients to chlorambucil, the standard first-line treatment for CLL, which should begin later this year.
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