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Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

March 19, 2017

Rituxan is a therapeutic antibody that binds to a particular protein, the CD20 antigen found on the surface of malignant cells as well as normal B-cells. In non-Hodgkin's lymphoma and rheumatoid arthritis (RA), Rituxan works with the body's natural defenses to attack and kill the marked CD20 positive B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing B-cells to regenerate after treatment and return to normal levels in about 12 months for most patients.

Rituxan first 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 as a single agent. It was also approved in the European Union under the trade name MabThera in June 1998. Rituxan is also approved for the treatment of non-Hodgkin's lymphoma for the following:

Previously untreated follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma as a single agent, after first-line CVP chemotherapy. Previously untreated 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 received FDA approval for rheumatoid arthritis in February 2006 and is currently indicated in combination with methotrexate (MTX) to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to severely-active rheumatoid arthritis who have had inadequate response to one or more TNF antagonist therapies.

Genentech and Biogen Idec co-market Rituxan in the U.S., and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Rituxan Safety

Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML).

Hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease-modifying anti-rheumatic drugs (DMARDs) other than MTX are used concomitantly.

The most common adverse reactions observed in Rituxan-treated RA patients are hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus and pyrexia.

The most common adverse reactions observed in Rituxan-treated NHL patients (incidence greater than or equal to 25 percent) are infusion reactions, fever, chills, infection, asthenia and lymphopenia.

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