Posted on February 10th, 2011 by
The U.S. Food and Drug Administration (FDA) has expanded the approval of Rituxan® (rituximab) to include maintenance therapy for patients with advanced follicular lymphoma that has responded to initial treatment with Rituxan and chemotherapy.
Follicular lymphoma is an indolent (slow-growing) type of non-Hodgkin’s lymphoma. It involves a type of white blood cell known as a B cell.
Rituxan is a targeted therapy that binds to a marker known as CD20 on the surface of B-cells. This binding prompts the immune system to destroy the cell, and may also have direct anticancer effects on the cell. Rituxan is commonly used in the treatment of non-Hodgkin’s lymphoma, and more recent studies have shown that it’s also active against chronic lymphocytic leukemia.
Maintenance therapy refers to longer-term treatment that is given after patients achieve remission with standard therapy. The goal of maintenance therapy is to prolong remission.
Approval of Rituxan as maintenance therapy for follicular lymphoma was based on the results of a Phase III clinical trial known as PRIMA. The study enrolled patients with advanced follicular lymphoma that had been reduced or eliminated by initial treatment with a combination of chemotherapy and Rituxan. Half the study participants were assigned to receive an additional two years of Rituxan as maintenance therapy, and half received no maintenance therapy. The results of the PRIMA study showed that Rituxan maintenance therapy delayed cancer progression.
Reference: Genentech news release. FDA approves Rituxan for first-line maintenance use in follicular lymphoma. January 28, 2011.
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