Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan(R) (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, M.D., 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."

Non-Hodgkin's lymphoma (NHL) is the fourth most common cancer in the United States. An estimated 360,000 Americans have NHL and more than 58,000 new cases are diagnosed annually. Diffuse large B-cell lymphoma (DLBCL), an aggressive subtype of NHL, divides and multiplies rapidly in the body, and if left untreated, can be fatal. However, early diagnosis and treatment can improve chances of long-term survival. Of those diagnosed with NHL, about 50 percent have an aggressive form of the disease, the most common type being DLBCL. The other 50 percent of patients have a slow-growing, but usually incurable or indolent form of the disease, of which the most common type is follicular lymphoma. Clinical Studies

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. In each study, hazard ratios for the time-to-event comparison, as well as the overall survival benefit, favored the Rituxan-containing arms. Results were generally consistent across subgroups, including age, gender and disease prognostic variables. With two years of follow-up, more patients were alive in the Rituxan-containing versus control arms for each study. In one of the studies with five years of follow-up, the GELA trial, R-CHOP improved overall survival by 47 percent compared to CHOP alone (a hazard ratio of 0.68, which is equivalent to a 32 percent decrease in the risk of death).

The studies included in the submission to the FDA were GELA/LNH 98-5 (the Group d'Etude des Lymphome d'Adulte also known as the GELA trial), E4494 (a National Cancer Institute-sponsored Intergroup trial led by the Eastern Cooperative Oncology Group) and MInT (MabThera International Trial M39045). Rituxan is known as MabThera in Europe.

The GELA trial was designed to evaluate the efficacy and safety of Rituxan in combination with induction CHOP chemotherapy in 399 patients 60 years of age or older with DLBCL. Patients were randomized to receive chemotherapy or Rituxan plus chemotherapy. At five years an estimated 58 percent of patients who received Rituxan plus chemotherapy were alive versus 46 percent of patients who received chemotherapy alone. Results of this trial were previously presented publicly in 2000 at the American Society of Hematology annual meeting and in 2001 at the American Society of Clinical Oncology annual meeting and were published in the New England Journal of Medicine in January 2002.

In addition to GELA, the MInT and E4494 trials demonstrated an overall survival benefit with the addition of Rituxan to chemotherapy in a wide range of patients. In the MInT trial, the addition of Rituxan significantly increased survival in younger (