FDA OKs New Anti-Cancer Treatment

WASHINGTON — The Food and Drug Administration on Wednesday approved a novel, genetically engineered drug to attack an incurable type of non-Hodgkin’s lymphoma 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.

“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 relapses over six or seven years.

These patients try high doses of chemotherapy, radiation and bone marrow transplants that can cause severe side effects.

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, said FDA monoclonal antibody chief Kathryn Stein. But ultimately these antibodies zero in on the white blood cells involved in non-Hodgkin’s lymphoma and trigger their death.

Rituxan therapy does not require hospitalization. Manufacturers IDEC Pharmaceuticals and Genentech Inc. say Rituxan, known chemically as rituximab, will be available within a month.

The FDA also approved:

* The first drug to help cancer patients avoid transfusions of blood platelets. The genetically engineered drug, interleukin-11, is intended just for patients whose chemotherapy destroys their platelets, which help blood clot.

* A new option for migraine sufferers. The pill, called Zomig, promises most users some relief from the pounding within two hours.