FDA Approves Rituxan Plus CHOP as a First-Line Treatment for Diffuse B-Cell NHL

Genentech and Biogen Idec announces 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 (NHL), 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."

An estimated 360,000 Americans have non-Hodgkins lymphoma (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. 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 studies of Rituxan in combination with CHOP or other anthracycline-based chemotherapy induction regimens in 1,854 previously untreated (first-line) patients with DLBCL. 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.

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.

"The best chance to achieve treatment success is in the first-line setting and these data demonstrate that first-line treatment with up to eight cycles of Rituxan plus chemotherapy resulted in a significant ...

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