Campath Approved for B-Cell CLL

MONTVILLE, NJ—The FDA has approved Campath (alemtuzumab) humanized monoclonal antibody for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have been treated with alkylating agents and have failed fludarabine (Fludara) therapy. Campath was developed by M&I Partners, a 50-50 joint venture of Millennium Pharmaceuticals, Inc. and ILEX Oncology, Inc. The agent will be marketed and distributed in the United States by Berlex Laboratories, Inc.

Campath binds to CD52, an antigen present on the surface of certain leukemia lymphocytes, which induces antibody-dependent cell lysis.

Approval was based on results of one large single-arm trial and two smaller studies showing overall response rates of 33%, 21%, and 29%, and median duration of response of 7 months, 7 months, and 11 months, respectively.

Due to excess mortality attributed to therapy-related complications in these studies, Campath will include a boxed warning concerning therapy-related hematologic toxicity, infusion reactions, and infections. For prescribing information, see www.berlex.com.