DATE: Friday, November 28, 1997             TAG: 9711280077

SECTION: FRONT                   PAGE: A9   EDITION: FINAL 

SOURCE: ASSOCIATED PRESS 

DATELINE: WASHINGTON                        LENGTH:   63 lines

FDA APPROVES DRUG TO TREAT NON-HODGKIN'S LYMPHOMA FDA SAYS RITUXAN HAS AN ``EXCELLENT'' SUCCESS RATE IN SHRINKING TUMORS SAFELY.

Thousands of patients with an incurable type of non-Hodgkin's lymphoma won their first new weapon in a decade this week.

The Food and Drug Administration on Wednesday approved a novel, genetically engineered drug to attack the immune system cancer with far fewer side effects than standard treatment.

Rituxan is not a cure, but the FDA said it has an ``excellent'' success rate in shrinking tumors safely.

The approval makes Rituxan the nation's first anti-cancer monoclonal antibody - a long-awaited biotherapy in which specially manufactured antibodies bind to cancer cells and trigger the immune system to do the killing instead of toxic chemicals.

One patient who tested Rituxan called the approval ``something to celebrate this Thanksgiving.''

``Even though my type of lymphoma is still considered incurable, Rituxan has renewed my hope of raising my three children,'' said Dr. Wendy Harpham, a Richardson, Texas, physician who failed other treatments before Rituxan therapy put her cancer in remission.

About 240,000 Americans have non-Hodgkin's lymphoma, a cancer of the lymph system that targets vital white blood cells. Many patients are successfully treated. But about half of them have an incurable form called low-grade non-Hodgkin's that causes repeat relapses over six or seven years.

These patients try high doses of chemotherapy, radiation and bone marrow transplants that can cause severe side effects, particularly when these treatments also kill healthy cells that get in the way.

Rituxan, on the other hand, is made from a genetically engineered mouse antibody designed to be a more specific treatment. Scientists don't know exactly how it works, FDA monoclonal antibody chief Kathryn Stein said. But ultimately these antibodies zero in on the white blood cells involved in non-Hodgkin's lymphoma and trigger their death.

``This is the first of what we hope will be many monoclonal antibodies for tumor treatment,'' she said.

In a study of 166 patients with advanced cancer, 48 percent had their tumors shrink by at least half. Six percent of the patients had complete remissions. Half the successful patients remained stable for more than 11 months, a rate that Stein called ``excellent.''

Rituxan therapy does not require hospitalization. Manufacturers IDEC Pharmaceuticals and Genentech Inc. say Rituxan, known chemically as rituximab, will be available within a month. A complete course of four weekly transfusions will cost roughly $9,000, comparable to many chemotherapies.

Rituxan has some risks. It can kill healthy white blood cells as well as cancerous cells, meaning patients could suffer infections although no unusual rates have appeared so far, said Dr. Peter McLaughlin of the M.D. Anderson Cancer Center, the drug's lead investigator. Those cells grow back on their own within a year.

Additionally, most patients have temporary and mild flu-like symptoms, such as fever and chills, one to two hours after the first infusion, as their bodies learn to recognize the new antibody, he said.

So few side effects make Rituxan a prime candidate to give to lymphoma patients in addition to chemotherapy, hoping for a one-two punch, McLaughlin said. KEYWORDS: FDA

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