The US Food and Drug Administration has approved Genentech and Biogen Idec's Rituxan (rituximab) for use in the first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma, in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. Rituxan has previously been approved as a single agent for use in relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma.

"Diffuse large B-cell lymphoma can be fatal within as little as six months to two years without aggressive treatment," said Sandra J. Horning, chair, lymphoma group for the Eastern Cooperative Oncology Group.

"With this approval, Rituxan in combination with chemotherapy becomes the first FDA approved treatment to improve survival for patients with this type of non-Hodgkin's lymphoma since the introduction of the CHOP chemotherapeutic regimen more than 25 years ago," added Horning.

The approval was 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 (first-line) patients with DLBCL

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 in June 1998 and based on the results of the GELA trial, was approved by the European Agency for the Evaluation of Medicinal Products (EMEA) for aggressive NHL in combination with CHOP chemotherapy. Genentech and Biogen Idec co-market Rituxan in the United States.

An estimated 3,60,000 Americans have non-Hodgkins lymphoma (NHL) and more than 58,000 new cases are diagnosed annually.