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FDA Approves Campath (Alemtuzumab) Humanized Monoclonal Antibody for B-Cell Chronic Lymphocytic Leukemia CAMBRIDGE, MA -- May 8, 2001 -- The U.S. Food and Drug Administration (FDA) today cleared Campath® (alemtuzumab) humanized monoclonal antibody for marketing as a treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alkylating agents and have failed fludarabine therapy. With this decision, Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany, will provide patients with refractory B-CLL a new treatment option. Campath therapy for B-CLL was developed by M&I Partners, a 50-50 joint venture of Millennium Pharmaceuticals, Inc., and ILEX Oncology, Inc. Campath will be marketed and distributed in the United States by Berlex Laboratories, Inc., of Montville, New Jersey. "This approval is good news for patients with refractory B-CLL. Campath provides a new option for refractory patients who have no other approved therapeutic options available," said Kanti Rai, M.D., chief of the division of hematology and oncology, Long Island Jewish Medical Center and a principal investigator in the Campath clinical trials. Chronic lymphocytic leukemia is the most prevalent form of adult leukemia, affecting approximately 120,000 patients in the U.S. and Europe. B-CLL is characterized by an accumulation of leukemic (malignant) lymphocytes that often bear the CD52+ antigen, in the bone marrow, blood, and other tissues. As a result of the accumulation of malignant lymphocytes, bone marrow dysfunction and enlargement of the lymph nodes, liver, and spleen may occur. Patients with B-CLL may suffer from disease-related symptoms such as fatigue, bone pain, night sweats, and decreased appetite and weight loss. Campath appears to work by targeting the CD52+ antigen on the malignant lymphocytes. Campath binds to CD52+, an antigen that is present on the surface of certain leukemic lymphocytes, and induces antibody-dependent lysis (killing) following binding. This results in the removal of the malignant lymphocytes from the blood, bone morrow, and other affected organs. In responders, treatment with Campath may improve blood counts and decrease the size of the liver and spleen. The CD52+ antigen is also found on nonmalignant (normal) lymphocytes, monocytes, macrophages, NK cells, some granulocytes, and some normal bone marrow cells. Campath should be administered under the supervision of a physician experienced in the use of antineoplastic agents. Hematologic toxicity: Serious and, in rare instances fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia have occurred in patients receiving Campath therapy. Infusion reactions: Campath can result in serious infusion reactions. Infections, opportunistic infections: Serious, sometimes fatal bacterial, viral, fungal, and protozoan infections have been reported in patients receiving Campath. In evaluating Campath, the FDA reviewed efficacy data from a single arm, clinical trial (Study 211) involving 93 patients with B-CLL, as well as two earlier supporting trials involving 32 B-CLL patients (Study 005) and 24 B-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 alkylating agents and were refractory to fludarabine. In Study 211, an overall response rate of 33 percent (31 of 93 patients) was observed with a median duration of response of about seven months. Response rates on the two supporting trials were 21 percent (7 of 32 patients) and 29 percent (7 of 24 patients) respectively, while the median durations of response were about seven and eleven months, respectively. In Study 211, a 30 percent mortality rate (28 deaths) was observed on study or within six months after completion of the study. Half of these deaths were determined to be due to the progression of B-CLL and half were due to complications related to Campath therapy. Adverse events associated with Campath therapy include infusion-related events, infections, and hematological toxicity. Common infusion-related toxicities included fever and rigors in over 80 percent of patients treated with Campath, nausea, vomiting, and rash in 40 percent of patients, and hypotension in about 32 percent of patients. Most of these events were mild (National Cancer Institute Common Toxicity Criteria [NCI-CTC] Grade 1 or 2) with serious (NCI-CTC Grade 3 or 4) events in less than 20 percent of patients. Infusion-related events are usually controlled with premedication and post-therapy medications including acetaminophen, diphenhydramine, corticosteroids, and meperidine. In the most recent study (Study 211) infections of any severity, including sepsis and pneumonia, were reported in about 44 percent of the study population. About 75 percent of these infections were serious (NCI-CTC Grade 3 or 4) in nature and about 20 percent were fatal. Slightly more than half of these serious (NCI-CTC Grade 3 or 4) infections occurred on study or within thirty days after completion of therapy with the others occurring two to six months after discontinuation of therapy. Opportunistic infections such as CMV, Candidiasis, Aspergillosis, Mucormycosis, Pneumocytiis carinii pneumonia (PCP), Herpetic infections, and Cryptococcus were reported in about 25 percent of the study population. Use of prophylaxis with trimethoprimsulfa appears to have reduced the incidence of PCP infections on this study. Antiviral prophylaxis with famciclovir was also utilized. It is not known if prophylaxis affected the incidence of viral infections. Hematological toxicities that were observed in the three studies included anemia in 80 percent of the study participants with serious (NCI-CTC Grade 3 or 4) anemia in 38 percent, neutropenia in 85 percent with serious (NCI-CTC Grade 3 or 4) neutropenia in 64 percent, and thrombocytopenia in 72 percent with serious (NCI-CTC Grade 3 or 4) thrombocytopenia in 50 percent. Other serious hematological toxicities include serious and sometimes fatal bone marrow hypoplasia, autoimmune hemolytic anemia, and autoimmune thrombocytopenia related to Campath therapy. In most instances, hematological toxicity resolved within two months of discontinuation of Campath therapy, however in others, complete recovery was not documented with follow-ups of more than one year. "Berlex is extremely pleased to offer patients with refractory B-CLL a new treatment option," said Dale A. Stringfellow, Ph.D., president and CEO of Berlex Laboratories, Inc. "Berlex has a rich history in oncology, and the arrival of Campath in the marketplace further demonstrates our commitment to the community of refractory B-CLL patients and caregivers. Campath, the newest product in Berlex's oncology portfolio, represents the most recent advance in CLL therapy." SOURCE: Millennium Pharmaceuticals, Inc. Related Links: Millennium Pharmaceuticals, Inc., ILEX Oncology, Inc. and Berlex Laboratories, Inc. E-mail this page to a friend or colleague! To print, use this version