Genentech And Biogen Idec Submit Supplemental Biologics License Application For First-Line Use Of Rituxan® In Low-Grade Or Follicular CD20-Positive B-Cell Non-Hodgkin’s Lymphoma
SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass. - March 30, 2006 - Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced today that the companies submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of Rituxan® (Rituximab) as first-line treatment of previously-untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisone) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy or following CVP chemotherapy in those patients who achieved a response of stable disease or better.
The sBLA submission is primarily based on efficacy and safety data from two randomized, controlled studies of Rituxan in 644 previously-untreated patients. The first study was a Phase III trial in 322 patients with follicular, CD20-positive, B-cell NHL that met its primary endpoint of an improvement in progression-free survival when Rituxan was used in combination with CVP chemotherapy as compared to CVP chemotherapy alone.
The submission also includes data from a Phase III trial of Rituxan given in a series of infusions over a two year period of time designed to evaluate efficacy and safety in 322 patients who had achieved a response or demonstrated stable disease to first-line CVP chemotherapy and who were then randomized either to receive Rituxan or observation. This study, E1496, a National Cancer Institute-sponsored intergroup trial led by the Eastern Cooperative Oncology Group, met its primary endpoint of an improvement in progression-free survival.
Rituxan is already approved as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL; Rituxan in combination with CHOP or other anthracycline-based chemotherapy was approved in February as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). Also in February, Rituxan was approved in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
About Non-Hodgkin’s Lymphoma
An estimated 360,000 Americans have non-Hodgkin’s lymphoma (NHL) and more than 58,000 new cases are diagnosed annually. Of those diagnosed with NHL, about 50 percent of patients have a slow-growing, but usually incurable (low-grade) form of the disease -- the most common type is called follicular lymphoma. The other 50 percent have a faster-growing subtype of NHL, which divides and multiplies rapidly in the body, and if left untreated, can be fatal.
Rituxan Safety Profile
The safety profile of Rituxan has been established in more than 730,000 patient exposures over a period of eight years.
In non-Hodgkin’s lymphoma, the majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like illness, fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema and hypotension. These symptoms vary in severity and generally are reversible with medical intervention.
In general, the adverse events observed in patients with RA were similar in type to those seen in patients with NHL. The most common adverse events observed in patients treated with Rituxan in RA clinical trials were infusion reactions and infections. No significant change in average immunoglobulin levels was observed in Rituxan-treated patients in clinical trials. There was no increase in hematologic malignancies, demyelinating events or risk of opportunistic infections (including tuberculosis) in Rituxan-treated patients over 24 weeks of treatment. Although five percent of Rituxan-treated patients developed human anti-chimeric antibodies (HACA), this was not associated with loss of clinical response or additional safety observations.
Severe infusion reactions have been reported in patients treated with Rituxan, some with fatal outcomes in patients with NHL. These severe reactions typically occur during the first infusion. The most severe manifestations and sequelae include pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, and anaphylactic and anaphylactoid events. Patients who develop clinically significant infusion reactions should have their Rituxan infusion discontinued and receive medical treatment. Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of tumor lysis syndrome following treatment with Rituxan. Severe mucocutaneous skin reactions, some with fatal outcome, have been reported in association with Rituxan treatment. Patients experiencing a severe mucocutaneous reaction should not receive any further infusions and seek prompt medical evaluation. Abdominal pain, bowel obstruction and perforation, in some cases leading to death, were observed in patients receiving Rituxan in combination with chemotherapy for diffuse large B-cell, CD20-positive, NHL. Other serious or potentially life-threatening adverse reactions that have been reported following Rituxan therapy include Hepatitis B reactivation with fulminant hepatitis, other viral infections, hypersensitivity reactions, and cardiac arrhythmias.
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 with significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis, 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 and in February 2006, Rituxan received FDA approval for the treatment of DLBCL in combination with CHOP or other anthracycline-based chemotherapy regimens in previously untreated patients. Also in February 2006, Rituxan in combination with MTX was approved to reduce signs and symptoms in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist therapies. It was approved in the European Union under the trade name MabThera®.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets the drug as MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. Rituxan is the top-selling oncology therapeutic in the United States. For a copy of the Rituxan full prescribing information, including Boxed Warnings, please call 1-800-821-8590 or visit http://www.gene.com.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
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