DOI: 10.1097/01.COT.0000312857.70372.fb

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Issn Print: 0276-2234

Publication Date: 2001/02/01


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Campath Recommended for Approval for CLL Patients Who Have Failed to Respond to Prior Therapy

Margot J. Fromer

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Excerpt

BETHESDA, MD—Campath (alemtuzumab) is a humanized monoclonal antibody directed against the CD52 antigen. It is indicated for treatment of patients with chronic lymphocytic leukemia (CLL) who have been treated with alkylating agents and who have failed fludarabine therapy.
The drug's sponsors, Millenium & ILEX Partners, LP, convinced members of ODAC to unanimously recommend its approval.
Michael J. Keating, MB, Professor of Medicine at MD Anderson Cancer Center in Houston, noted that CLL is the most common form of adult leukemia in the United States. Prevalence is about 60,000 patients, who are an average 58 years old at time of diagnosis. The disease is progressive and usually fatal. Most patients die of complications, often infection, but also bone marrow failure and immunosuppression.
There are a number of standard treatments for CLL: alkylating agents as first line and fludarabine as second line. Only the latter has been approved for the indication. There are no third-line treatments.
Several published studies of fludarabine show a reduced tumor burden (which is the most significant cause of complications), tumor response, and some clinical benefit such as improvement in fever, fatigue, night sweats, and weight loss. However, the response rate is less than stellar (21% to 48%), and the number and severity of complications are high. Median survival is only nine to 12 months.
Dr. Keating concluded: “Even after second-line fludarabine therapy, median survival is less than a year, and there is substantial morbidity. Third-line investigational therapy has produced a median survival of only three to 10 months. Therefore, new and effective treatments are urgently needed for this disease.
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