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(rituximab, Genentech, Biogen Idec)

A therapeutic monoclonal antibody approved as first-line treatment for diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma (NHL), taken in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or with other anthracycline-based chemotherapy regimens. In 1997, Rituxan was the first monoclonal antibody approved for cancer, when it was approved for treating relapsed or refractory low-grade or follicular CD20-positive, B-cell NHL.

* Recommended Dosage: 375 mg/[m.sup.2] administered intravenously on the first day of each chemotherapy cycle for up to eight infusions.

* Special Considerations: Infusion-related symptoms, generally reversible, are common with the first infusion. Severe infusion reactions and severe mucocutaneous skin reactions have been reported, including some deaths.

* Comment: Rituxan is a monoclonal antibody directed at the CD20 antigen, present on the surface of normal and malignant B lymphocytes and expressed on more than 90% of B-cell NHLs, but not on hematopoietic stem cells or normal plasma cells. It "targets and selectively depletes CD20-positive B-cells, without targeting stem cells or existing plasma cells," according to Genentech Inc. and Biogen Idec Inc., comarketers in the United States.

Approval of the expanded indication was based on three randomized trials of 1,854 patients comparing CHOP or other anthracycline-based chemotherapy with or without Rituxan; the data showed greater survival at 2 years in patients in the CHOP plus Rituxan (R-CHOP) group. In one of the studies with 5-year follow-up data, overall survival continued to be greater in patients treated with R-CHOP.

In the two studies with patients aged 60 years and older, overall survival was 63% at 2 years and 46% at 5 years for those in the CHOP group, versus 74% and 58% among those in the R-CHOP group.
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Title Annotation:Approved as first-line treatment for diffuse large B-cell
Author:Mechcatie, Elizabeth
Publication:Internal Medicine News
Article Type:Brief article
Geographic Code:1USA
Date:Mar 15, 2006
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