MONTVILLE, NJThe 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.