Campath Approval Deaths in Trial

Millennium Leukemia Drug Wins FDA Approval Despite Safety Concerns

The leukemia therapy Campath (alemtuzumab), developed through Millennium Pharmaceutical's 50/50 joint venture with Ilex Oncology, has received US Food and Drug Administration approval, the companies said on Monday.

The approval clears Campath for use in patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alkylating agents and have failed fludarabine therapy. It comes despite worries about deaths in clinical trials.

"Campath provides a new option for refractory patients who have no other approved therapeutic options available," according to Long Island Jewish Medical Center's Dr. Kanti Rai, who was a principal investigator in clinical trials of the treatment.

In the most recent study of Campath, a 30% mortality rate was observed, with roughly half of those deaths attributed to therapy-related complications, including hematological toxicities such as bone marrow hypoplasia. In the same study, there was a high incidence of infection among those treated with Campath.

Campath will carry a boxed warning alerting physicians to the hematologic toxicity, infusion reactions and infections that can be associated with the therapy.

"The question that no one can answer is [whether B-CLL patients are] better off getting Campath or [whether the best option is] just leaving them alone and letting the disease take its natural course, which in most cases would be fatal," said Dr. Jeff Lattf, chief medical officer at Berlex Laboratories, the company that will market and distribute the treatment in the US.

In the most recent study, there was an overall response rate of about 33%, with a median duration of response of about 7 months. In two smaller trials, response rates were 21% and 29%, with median duration of response of about 7 and 11 months, respectively.

In late 2000, an FDA advisory committee voted 14 to 1 to recommend accelerated approval of Campath, which allows a drug to reach the market while outstanding questions are answered through follow-up research. Dr. Lattf said that additional trials to help assess Campath's risk-benefit profile are expected, but trial designs have not been set.

Campath is a humanized monoclonal antibody that targets the CD52 antigen, found on B and T lymphocytes. Millennium said that the antibody destroys these lymphocytes in several ways, including via apoptosis.

The therapy was recently recommended for approval in the European Union, where it will be sold as MabCampath. Final EU approval is anticipated in the second half of the year, according to a Berlex spokesman.

As a monotherapy or in combination with other drugs, Campath is being considered for treatment of other hematological cancers including peripheral and cutaneous T-cell lymphoma, treatment of autoimmune diseases such as multiple sclerosis, and prevention of organ transplant rejection, the spokesman said.

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