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FDA Grants Priority Review for Rituxan (Rituximab) Supplemental Biologics License Application for Front-Line Treatment of Intermediate-Grade or Aggressive Non-Hodgkin's Lymphoma SOUTH SAN FRANCISCO, CA, and CAMBRIDGE, MA -- October 25, 2005 -- Genentech, Inc. and Biogen Idec, Inc. announced today that the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) submitted by the companies for Rituxan(R) (rituximab) in previously-untreated (front-line) patients with intermediate grade or aggressive, CD20-positive, B-cell, non-Hodgkin's lymphoma (NHL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. Based on the designation of Priority Review, the FDA has up to six months from the submission date, or by the middle of February 2006, to take action on the sBLA submission. The sBLA was submitted on August 12, 2005. The sBLA filing is based on efficacy and safety data from three randomized, controlled, multicenter studies of Rituxan in combination with CHOP or other anthracycline-based chemotherapy induction regimens in 1,854 previously untreated patients with intermediate grade or aggressive, CD20-positive, B-cell, non-Hodgkin's lymphoma. All three trials evaluated the efficacy endpoint of overall survival. About Non-Hodgkin's Lymphoma There are currently more than 360,000 people in the United States living with NHL. Approximately 50 percent have aggressive NHL, while the other half have indolent or follicular lymphoma. According to the American Cancer Society, more than 56,000 men and women in the United States are diagnosed with NHL each year. Rituxan Safety Profile In NHL patients, the majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema and hypotension. These symptoms vary in severity and generally are reversible with medical intervention. In rare instances, severe and fatal infusion-related reactions have occurred, nearly all of which have been associated with the first Rituxan infusion. These events appear as manifestations of an infusion-related complex and include hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock and tumor lysis syndrome. Patients who develop clinically significant infusion-related cardiopulmonary events should have their Rituxan infusion discontinued and receive medical treatment. In rare instances, severe mucocutaneous skin reactions have occurred that may be associated with Rituxan therapy. Many of these reactions have been described as paraneoplastic pemphigus and are known to be associated with various B-cell lymphomas, particularly NHL and chronic lymphocytic leukemia (CLL). Patients who develop a severe mucocutaneous skin reaction should have Rituxan discontinued and receive appropriate medical treatment including a skin biopsy to guide therapy. About Rituxan Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells. Rituxan is also being studied in other hematologic malignancies as well as autoimmune diseases, including rheumatoid arthritis, lupus, multiple sclerosis and ANCA-associated vasculitis. Rituxan, discovered by Biogen Idec, received FDA approval in November 1997 for the treatment of relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). It was approved in the European Union under the trade name MabThera(R) in June 1998. Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. Rituxan has been used to treat more than 730,000 patients worldwide. SOURCE: Genentech, Inc. E-mail this page to a friend or colleague! To print, use this version