New Drug for Non-Hodgkin's Lymphoma Now Available In The U.S.
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New Drug for Non-Hodgkin's Lymphoma Now Available In The U.S.

SOUTH SAN FRANCISCO, CA and SAN DIEGO, CA -- December 17, 1997 -- Genentech, Inc. and IDEC Pharmaceuticals Corp. announced that Rituxan(TM) (Rituximab) is being shipped today to the oncology medical community. Rituxan was cleared for marketing by the United States Food and Drug Administration (FDA) on November 26, 1997.

Previously known 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 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 U.S.

IDEC discovered Rituxan and developed the product in collaboration with Genentech, F. Hoffmann-La Roche, Ltd. of Switzerland and Zenyaku Kogyo Co., Ltd. of Japan. IDEC and Genentech co-promote Rituxan in the U.S. and have shared responsibility for product manufacture. Roche is responsible for marketing the product under the tradename MabThera in the rest of world, excluding Japan.

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