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FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
Date:9/22/2007

cell chronic lymphocytic leukemia (B-CLL) are diagnosed in the U.S. each year. It is the largest subset of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia in the western world. B-CLL is characterized by the accumulation of functionally immature cells in the bone marrow, blood, lymph tissue and other organs. Because these cancerous B cells have a longer than normal life span, they begin to build up and "crowd out" normal, healthy blood cells and can become fatal. Symptoms include fatigue, bone pain, night sweats, fevers, and decreased appetite and weight loss. Bone marrow infiltration leads to a lack of healthy blood cells, thus causing susceptibility to bleedings and weakening of the immune system, exposing the patient to a higher risk of infection.

Additional Information About Campath

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath has a boxed warning which includes information on cytopenias, infusion reactions, and infections. The most commonly reported adverse reactions are infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion
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SOURCE Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc.
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