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| T02-11 | Media Inquiries: 301-827-6242 |
| February 19, 2002 | Consumer Inquiries: 888-INFO-FDA |
FDA today approved a novel treatment regime for one type of non-Hodgkins Lymphoma (NHL) that for the first time includes a monoclonal antibody that is combined with a radioactive chemical. The product, Zevalin, must be used along with Rituxan, an already approved biotechnology product for the disease -- low-grade B-cell NHL. It is approved for patients who have not responded to standard chemotherapy treatments or to the use of Rituxan alone.
Zevalin is manufactured by IDEC Pharmaceuticals Corporation, San Diego, Calif. Rituxan was co-developed by IDEC and Genentech, Inc., San Francisco, Calif and is manufactured by Genentech, Inc.
Rituxan and Zevalin are monoclonal antibodies that target white blood cells (B-cells), including the malignant B cells involved in the disease, resulting in significant tumor shrinkage. The Zevalin therapeutic regimen targets tumor cells with a high dose of radiation reducing the amount of full body radiation.
The Zevalin therapeutic regimen is administered in two parts. Patients first receive Rituxan followed by a form of Zevalin with a low dose of radioactive chemical for screening purposes. If patients’ tumors are properly targeted with this procedure, they receive Rituxan again with a form of Zevalin that has a different radioactive chemical that can provide a treatment benefit.
Two multi-center trials were conducted to demonstrate the safety and efficacy of the Zevalin therapeutic regimen. In the first trial, 54 patients who were no longer responding to chemotherapy or Rituxan received the Zevalin therapeutic regimen. The overall response rate was 74%. The second trial enrolled 143 patients who were not responding to chemotherapy but had not yet received Rituxan. The overall response rate in this trial was 80% compared to 56% for Rituxan. The duration of response was approximately 2 months longer with the Zevalin therapeutic regimen, although it is too early to say whether it will allow patients to live longer than Rituxan therapy. The manufacturer, IDEC, is conducting follow up studies.
The Zevalin treatment regimen is more toxic than treatment with Rituxan. More than half of the patients in the clinical trials experienced serious reductions in blood-cell counts, including white blood cells and platelets lasting for 3 to 4 weeks. Hemorrhages, some fatal, and life threatening infections occurred in a small number of patients. Because of these concerns, the Zevalin therapeutic regimen is only approved for patients who have failed other treatments.
The most common side-effects associated with Rituxan alone are related to the intravenous infusion, itself, and involve mild to moderate flu-like symptoms. Rituxan was approved Nov 1997 and was the first biotechnology product approved to treat NHL.
In the United States, approximately 55,000 people are diagnosed with NHL each year and about 65% 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 relapses that occur more frequently over the course of the disease. As patients are treated for subsequent relapses, their responses to standard treatments diminish. Zevalin will provide another treatment option for these patients.
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