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ODAC recommends Campath

December 14, 2000 8:00 AM UTC

An FDA advisory committee on Thursday voted 14-1 to recommend accelerated approval of Campath alemtuzumab, a monoclonal antibody developed by Millennium (MLNM) and Ilex (ILXO) as a third-line treatment for chronic lymphocytic leukemia (CLL). Accelerated approval is based on improvement of surrogates that are likely to predict clinical benefit and is contingent on the sponsors' commitment to conduct a follow-up trial to confirm clinical benefit. Oncologic Drugs Advisory Committee (ODAC) members said they were confident that Campath is effective in reducing tumor burden and improving the quality of life of CLL patients who have failed treatment with an alkylating agent and with fludarabine. ...