CHMP advocates MabCampath approval

Bayer Schering Pharma AG, part of Germany's Bayer, and US biotechnology firm Genzyme, say that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the anticancer agent MabCampath (alemtuzumab). Specifically, the committee said that the drug should be approved for B-cell chronic lymphocytic leukemia patients for whom treatment with fludarabine-based chemotherapy is not appropriate.

Earlier this month, Campath, the drug's US brand name, received clearance as a single-agent therapy for B-CLL from the Food and Drug Administration (Marketletter October 1). The FDA and the CHMP based their respective decisions on trial data which demonstrated that the agent increases progression-free survival 42% in treated patients compared with standard chlorambucil therapy.

Gunnar Riemann, a member of Bayer Schering Pharma's board, said: "the committee's recommendation underscores the potential of MabCampath to become a standard-of-care for patients with B-CLL." A final EMEA approval decision is expected before the end of the year.