FDA Approved Drugs » 1997
Medical Areas: Hematology | Oncology
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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
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.
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.
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.
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.
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.