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The United States Food and Drug Administration (FDA) has approved the targeted agent Rituxan® (rituximab) for two new indications: 1) as initial therapy for patients with follicular non-Hodgkin’s lymphoma (NHL) in combination with the chemotherapy combination known as CVP (cyclophosphamide, vincristine, and prednisolone); 2) for the treatment of patients with low-grade NHL whose cancer has regressed or stabilized following initial therapy with CVP.

Non-Hodgkin’s lymphoma is a form of cancer that begins in the cells of the lymph system. The lymph system includes the spleen, thymus, tonsils, bone marrow, lymph nodes, and circulating immune cells. The main cells in the lymph system are lymphocytes, of which there are two types: B- and T-cells. Each cell type has a specific function in helping the body fight infection.

NHL is characterized by the excessive accumulation of atypical (cancerous) lymphocytes. These lymphocytes can crowd the lymph system and suppress the formation and function of other immune and blood cells. NHL is categorized by the type of lymphocyte it involves and by the rate at which the cancer grows. Indolent, or slow-growing NHL, refers to disease that does not tend to grow or spread aggressively.

Rituxan is an agent that has been designed to bind to B-cells-the most common type of cancerous cell in NHL. Through this binding action, Rituxan stimulates the immune cells of the body to attack the cancerous cells. In addition, it is believed that Rituxan may have some direct cancer-killing properties.

The results prompting the approval of Rituxan as initial therapy in addition to CVP were from a phase III clinical trial including 322 patients with follicular NHL who had not received prior therapy. Patients were treated with either R-CVP or CVP alone.

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  • Patients treated with R-CVP had a lower progression-free survival (2.4 years) compared to those treated with CVP only (1.4 years).
  • R-CVP reduced the risk of cancer progression, cancer recurrences, and death by 56% compared to treatment with CVP only.

The results prompting the approval of Rituxan for use among patients who had received initial therapy with CVP and had achieved regression or stabilization of cancer included 322 patients who had just finished treatment with CVP. These patients achieved either partial or complete disappearances of cancer or cancer stabilization with CVP. Patients were then either treated with Rituxan every six months or no further treatment.

  • Patients who were treated with Rituxan had more than a 50% reduced risk of cancer progression, cancer recurrences, or death compared to patients who did not receive Rituxan.

Patients with either newly diagnosed NHL or those who have achieved regression or disease stabilization following CVP may wish to speak with their physician regarding their individual risks and benefits of treatment with Rituxan.

Reference: Genentech. FDA Approves Two New Indications for Rituxan in Patients with Non-Hodgkin’s Lymphoma. Available at: . Accessed September 2006.

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