FDA Approved Drugs » 1997
Medical Areas: Hematology | Oncology

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Rituxan

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Biogen IDEC, Genentech
Approval Status: Approved November 1997
Treatment Area: non-hodgkin's lymphoma

General Information

Rituxan, the first new treatment for non-hodgkin's lymphoma (NHL) in 10 years, was approved by the FDA. Rituxan is a sort of biologically engineered bloodhound that tracks down the immune system cancer to kill it. Rituxan significantly shrinks tumors with fewer side effects than traditional cancer therapy.

Unlike many cancer treatments, Rituxan therapy does not require hospitalization. Patients get four infusions one week apart.

Clinical Results

In a study of 166 patients with advanced cancer, 48% saw their tumors shrink by at least half. Six percent of patients had complete remissions. Half of all successful patients remained stable for more than 11 months. All of these patients had tried and failed at least one other form of chemotherapy.

Side Effects

Most patients suffer temporary and mild flu-like symptoms, such as fever and chills, one to two hours after the first infusion, as their body learns to recognize the new antibody.

Mechanism of Action

Rituxan, known chemically as rituximab, becomes the first monoclonal antibody sold in this country to treat cancer. Monoclonal antibodies, which actually seek out cancer cells and bind directly to them, are a long-awaited class of drugs that promise fewer side effects than traditional cancer treatments.

Additional Information

About 240,000 Americans have NHL, a cancer of the lymph system that targets white blood cells. Many patients can be successfully treated. But about half of these people have a severe form called low-grade NHL that can stay in remission for years but that eventually will strike again--and ultimately is incurable. These patients frequently get high doses of chemotherapy, radiation, and bone marrow transplants that can cause severe side effects.