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New cancer drug 'something to celebrate on Thanksgiving'
In this story:
November 26, 1997
- Hope for non-Hodgkin's lymphoma patients
- Rituxan targets cancerous cells
- 'The closest answer to my prayers so far'
- Related stories and sites
Web posted at: 8:24 p.m. EST (0124 GMT)WASHINGTON (CNN) -- The Food and Drug Administration has approved a novel, genetically engineered drug for the treatment of non-Hodgkin's lymphoma that one patient calls "something to celebrate on Thanksgiving."
Rituxan does not cure the disease -- a cancer of the immune system -- but the FDA said it has an "excellent" success rate in shrinking tumors safely.
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. And half of the successful patients remained stable for more than 11 months, a rate that FDA monoclonal antibody chief Kathryn Stein called "excellent."
The FDA's approval makes Rituxan the nation's first anti-cancer monoclonal antibody. The long-awaited biotherapy uses specially manufactured antibodies -- large protein molecules -- to bind to cancer cells and trigger the immune system to kill the cancer rather than relying on toxic chemicals. In doing so, they shrink tumors.
"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.
Rituxan targets cancerous cells
Non-Hodgkin's lymphoma is a cancer of the lymph system that targets white blood cells. About 240,000 Americans have the disease, and while many are successfully treated, about half have an incurable form called low-grade non-Hodgkin's that causes repeat relapses.
These patients try high doses of chemotherapy, radiation and bone marrow transplants that can cause severe side effects, particularly when the treatments 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, but ultimately the antibodies zero in on the cancerous 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," Stein said.
The manufacturers of Rituxan -- which is known chemically as rituximab -- are IDEC Pharmaceuticals and Genentech Inc. They say the drug will be available within a month and that a course of four weekly transfusions will cost about $9,000, a price that is comparable to chemotherapy.
Rituxan does have some risks. It can kill healthy white blood cells as well as cancerous ones, meaning that patients could suffer infections.
'The closest answer to my prayers so far'
However, Dr. Peter McLaughlin of the M.D. Anderson Cancer Center in Houston, the drug's lead investigator, said that no unusual infection rates have been found so far.
Also, the white cells grow back within a year.
Other side effects include temporary, mild flu-like symptoms such as fever and chills shortly after the first infusion as patients' bodies learn to recognize the new antibody.
Rituxan does not require hospitalization, and has so few side effects that it has become a prime candidate to give to lymphoma patients along with chemotherapy, McLaughlin said.
Doctors are studying how well such a combination could work, as well as the feasibility of giving it to earlier patients instead of waiting until they relapse.
But for the moment, Rituxan promises to buy time for many.
Harpham says if she hadn't gotten to test the drug, she would already have tried her last option, a bone marrow transplant that she still can turn to if she has another relapse.
Still, she said, "Rituxan has been the closest answer to my prayers so far."
The Associated Press contributed to this report.
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Related stories:
- Promising lymphoma treatment clears a hurdle - July 25, 1997
Related sites:
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- Food and Drug Administration Home Page
- Mike's Lymphoma Resource Pages
- The Lymphoma Research Foundation of America
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