Immunology Description Rituxan® (Rituximab) is a therapeutic antibody, which binds to the CD20 antigen on the surface of normal and malignant B-cells. From there, it recruits the body's natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

Development Status In the third quarter of 2008, we submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for the potential treatment of rheumatoid arthritis patients who have had an inadequate response to disease modifying anti-rheumatic therapies, or DMARDs.

Phase III clinical trials are ongoing evaluating Rituxan in autoimmune diseases, including active rheumatoid arthritis, antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis, and lupus nephritis.

Rituxan is being developed in collaboration with F. Hoffmann-La Roche and Biogen Idec Inc.

Approved Uses - Hematology/Oncology

• In November 1997, the FDA approved Rituxan for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma as a single agent.
• In April 2001, the FDA approved Rituxan for these additional uses: retreatment of patients with Rituxan who have relapsed following initial Rituxan therapy, use of eight weekly doses (compared to original four) per course of treatment, treatment of patients with bulky disease (lesions > 10 cm).
• In February 2006, the FDA approved Rituxan for the treatment of patients with previously untreated diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy or other anthracycline-based chemotherapy regimens.
• In September 2006, the FDA approved Rituxan for the treatment of patients with previously untreated follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy.
• In September 2006, the FDA approved Rituxan for the treatment of patients with non-progressing (including stable disease), low-grade, CD20-positive, B-cell, non-Hodgkin's lymphoma, as a single agent, after first-line treatment with CVP chemotherapy.

Approved Uses - Immunology

• In February 2006, the FDA approved Rituxan in combination with methotrexate to reduce signs and symptoms in adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
• In January 2008, the FDA approved Rituxan in combination with methotrexate for slowing the progression of structural damage in adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Read more about Rituxan's approved uses.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

October 2008