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| |  First New Drug for Non-Hodgkin's Lymphoma in Decade Cleared In U.S. SAN DIEGO and SOUTH SAN FRANCISCO, CA. -- Nov. 26, 1997-- IDEC Pharmaceuticals Corporation and Genentech, Inc. today announced that Rituxan(TM) (Rituximab) has been cleared for marketing by the U.S. Food and Drug Administration (FDA). Previously know as the C2B8 antibody, the drug is a single-agent monoclonal antibody therapy for the treatment of relapsed or refractory low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma. In the pivotal trial conducted at 31 U.S. sites, Rituxan, when used alone, showed a 48 percent overall response rate. Eighty of 166 patients experienced tumor shrinkage of 50 percent or greater following four weekly infusions. The median duration of response is projected to be 10-12 months. Patients continue to be monitored. These results corroborated those seen in earlier studies. In clinical trials, the most common adverse events associated with Rituxan were infusion-related, consisting mainly of mild to moderate flu-like symptoms (e.g., fever, chills, rigors) that occurred in the majority of patients during the first infusion. Other events which occurred with less frequency included nausea, rashes, fatigue and headache. More serious events included hypotension, wheezing, sensation of tongue or throat swelling and recurrence of cardiac events in patients with a history of angina or arrhythmia. These symptoms were usually limited in duration to the period of infusion and decreased with subsequent infusions. Rituxan is the first new single-agent therapy in 10 years for non-Hodgkin's lymphoma and the first monoclonal antibody licensed for the treatment of cancer in the United States. Rituxan also represents the first marketed monoclonal antibody product for Genentech's BioOncology initiative, and is the first marketed product for IDEC. It is expected to be commercially available for use within approximately three weeks. "Rituxan represents an important turning point in the treatment of lymphoma," said Myron Czuczman, M.D., Assistant Professor of Medicine, Roswell Park Cancer Institute, Buffalo, New York, and a key investigator. "Although it is not a cure, we finally have a cancer agent that can be effective with less serious side effects than with conventional chemotherapy. Treatment can also be completed in 22 days, unlike the typical four- to six-month chemotherapy regimens. This is exciting news, especially for elderly patients and relapsed patients who have failed at least one standard treatment regimen." There are approximately 250,000 patients in the United States with B-cell non-Hodgkin's lymphomas, which are malignancies of the body's antibody-producing immune system cells. Approximately one-half are low-grade or follicular lymphoma patients. A portion of these patients will have multiple relapses and may be eligible for Rituxan therapy. Currently, standard treatment consists of chemotherapy and/or radiotherapy. Unlike the typical four- to six-month chemotherapy regimen or high-dose radiation treatment, Rituxan can be administered in four infusions on an outpatient basis over a 22-day period. Rituxan works by binding to a particular protein (the CD20 antigen) on the surface of mature B cells and B-cell tumors. Then it recruits the body's natural defenses to attack and kill both malignant and normal mature B cells. Stem cells present in the bone marrow lack the CD20 antigen and are, therefore, not affected by the treatment. In clinical studies, B cells returned to normal levels within several months after completion of treatment. More information on: IDEC Pharmaceuticals Corporation, Genentech, Inc.
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