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| |  FDA Committee Recommends Campath (Alemtuzumab) For Leukemia BETHESDA, MD -- December 14, 2000 -- The Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 14 to one to recommend accelerated approval of Millennium & ILEX Partners L.P.'s (M&I Partners) Campath® (alemtuzumab) investigational humanized monoclonal antibody for patients with chronic lymphocytic leukemia (CLL) who have been treated with alkylating agents and have failed fludarabine therapy. CLL is the most prevalent form of adult leukemia, affecting approximately 120,000 patients in the United States and Europe. CLL is characterized by an accumulation of leukemic cells in the bone marrow, blood and other tissues, causing bone marrow dysfunction and enlargement of the lymph nodes, liver and spleen. Patients with CLL suffer from numerous disease-related symptoms, including fatigue, bone pain, night sweats and loss of appetite and weight. Investigators believe Campath works by targeting the CD52 antigen, which is prevalent on cancerous B lymphocytes, to clear the blood and bone marrow of cancer cells. The FDA Advisory Committee reviewed efficacy data for a pivotal Phase II (single arm) clinical trial (Study 211) involving 93 patients with CLL as well as two earlier supporting trials involving 32 patients (Study 005) and 24 CLL patients (Study 009) respectively. Seventy percent or more of the patients participating in each of these trials had advanced disease (Rai Stage III/IV). All of the study participants in Study 211 had received previous therapy with alklylators and were refractory to (had failed) fludarabine therapy. In the pivotal trial (Study 211) an objective response rate of 33 percent (31 of 93 patients) was observed with a median duration of response of about seven months. In Study 211 seven (23 percent) subjects had objective responses of more than one year. In the two supporting trials objective responses of 29 percent (Study 009) and 22 percent (Study 005) were reported. Three (43 percent) responders in Study 009 and two (29 percent) responders in Study 005 had objective responses lasting more that one year. Improvement/remission of disease-related symptoms and improvement in hematological parameters were noted in most responders who had symptoms or hematological compromise at initiation of Campath therapy. In Study 211, there was 30 percent mortality on study or within six months after completion of the study. Half of these were determined to be due to the progression of the disease and half due to complications. Adverse events associated with Campath therapy include infusion-related events, infections and hematological toxicity. Common infusion-related toxicities included fever, rigors, nausea, vomiting, rash and hypotension. Most of these events were mild (National Cancer Institute Common Toxicity Criteria Grade 1/2) and were controlled with premedication and appeared to decrease in occurrence over the duration of therapy. Infections of any severity were reported in about 50 percent of the study population. Half of these infections were serious in nature. Opportunistic infections were reported in about one-fourth of the study population. Hematological toxicities reported in the study included anemia, neutropenia and thrombocytopenia. Serious hematological toxicity (National Cancer Institute Common Toxicity Criteria Grade 3/4) noted in the study or shortly after completion of study drug therapy resolved within two months after discontinuation of therapy. "As a researcher dedicated to finding new treatments for CLL, I am excited and pleased that Campath is one step closer to providing an option that may help patients enjoy their lives for a longer period," said Dr. Michael J. Keating, deputy chairman of the Department of Leukemia at the University of Texas M.D. Anderson Cancer Center in Houston and principal Campath clinical investigator. The Advisory Committee's recommendation is not binding, but will be taken into consideration by the FDA upon completing the review of the Campath Biologics License Application (BLA), which was submitted to the FDA on Dec. 23, 1999. Additionally, M&I Partners submitted a Marketing Authorization Application (MAA) for Campath to the European Agency for the Evaluation of Medicinal Products (EMEA) for evaluation in March 2000, which is currently under review. Accelerated approval requires that M&I Partners further study the compound to verify and describe its clinical benefit. A post-approval clinical trial to examine Campath's safety and efficacy in CLL patients is being planned and is expected to begin in 2001. Campath was developed by M&I Partners, a 50-50 joint venture of Millennium Pharmaceuticals Inc. and ILEX Products Inc., a subsidiary of ILEX Oncology Inc. If approved by the FDA, it will be marketed and distributed in the United States by Berlex Laboratories Inc. of Richmond, Calif., the U.S. affiliate of Schering AG, Germany.
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