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Date: Wednesday, November 26, 1997
FOR IMMEDIATE RELEASE
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FDA today approved the first biotechnology product to treat patients with one type of non-Hodgkin's lymphoma (NHL), a cancer of the immune system.

The product, rituximab, is a monoclonal antibody that is effective for patients with low-grade B-cell NHL who have not responded to standard treatments. Rituximab targets and destroys white blood cells (B-cells) involved in the disease, resulting in significant tumor shrinkage with less severe side-effects than most cancer treatments.

In the United States, approximately 240,000 people have B-cell NHL, and about 50 percent of this group are of the low-grade or follicular subgroup of NHL, which is ultimately incurable. Patients with this type of NHL may remain in remission for years but eventually have multiple recurrences of their symptoms or relapses that occur more frequently over the course of the disease.

Rituximab is a genetically engineered version of a mouse antibody that contains both human and mouse components. It can be produced in large quantities in the laboratory.

Because specific cells are targeted with rituximab, rather than all fast-growing cells, as is the case for most chemotherapy, NHL patients suffer fewer serious side effects than with other treatments.

"Decades of basic scientific research have culminated in the first monoclonal antibody product to treat cancer," said Lead Deputy FDA Commissioner Michael A. Friedman, M.D. "Although not yet the magic bullet we are looking for, it will give patients and their physicians another less toxic treatment option when other treatments fail."

In the main clinical study of 166 patients with advanced low-grade or slow-growing NHL, tumors shrunk by at least one-half in 48 percent of the patients who completed the treatment with 6 percent having complete remissions.

All of these patients had received at least one other form of chemotherapy before the clinical trial. The positive results have been long-lasting, with half of the patients who responded staying in remission for more than 11 months. Studies on these patients are continuing.

The most common side effects associated with rituximab were related to the intravenous infusion itself and involved mild to moderate flu-like symptoms.

These symptoms occurred predominantly with the first treatment, were limited to the period of infusion and were less common and less severe with subsequent infusions. Hospitalization is not required to administer the product.

Because rituximab destroys healthy immune cells as well as cancerous ones, concerns existed about patients' being prone to infections.

However, patients in the clinical trial had no more infections than would be expected given their disease and damage to their immune systems from prior treatments.

IDEC Pharmaceuticals Corporation, San Diego, Calif., and Genentech, Inc., San Francisco, Calif., co-developed the product and will market it in the United States under the trade-name Rituxan. FDA completed its review of the license application in five months, and the product was approved four months later, following the resolution of outstanding issues.

Note: HHS press releases are available on the World Wide Web at: www.dhhs.gov.