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Feb. 19, 2002 |
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n Lung n Breast n General n Prostate n Leukemia n Lymphoma n Colon n News/Issues |
New lymphoma drug approach gets FDA approval SAN DIEGO -- Feb 19, 2002 (Cancer Digest) -- The FDA today recommended approval of a new drug that delivers radiation to individual non-Hodgkin's Lymphoma cells in patients who have become resistant to another drug called Rituxan. The new drug called Zevelin, made by IDEC Pharmaceuticals, uses an engineered antibody coupled to a radioactive isotope to deliver the radiation directly to cancerous lymph cells that display a particular protein on the cell surface. The technique is called radioimmunotherapy because it uses the immune system to deliver radiation to cancer cells. Zevelin is the first radioimmunotherapy to receive FDA approval. It is estimated that commercial shipments of Zevalin will begin within approximately 30 to 60 days. "Zevalin represents a major advance in the treatment of certain non-Hodgkin's lymphomas, especially among patients who have become refractory to other treatment options," said Dr. Thomas E. Witzig, a hematologist at the Mayo Clinic, Rochester, MN, and a key investigator in the trials. "Zevalin is a significant step forward in managing patients with adequate bone marrow reserves who have failed standard chemotherapy, Rituximab therapy, or a combination of chemotherapy and Rituxan. And, unlike standard chemotherapy, which is given over as many as four to six months, Zevalin can be administered in an outpatient setting over eight days with approximately 12 weeks of follow-up." Zevalin received two separate approvals, a full approval and an accelerated approval, based on two major efficacy studies in the U.S. Determination of the effectiveness of the Zevalin therapeutic regimen in are lapsed or refractory patient population was based on overall response rates (ORR). The effects of the Zevalin therapeutic regimen on survival are not known. The first study, on which the full approval is based, involved 54 patients with relapsed follicular lymphoma who no longer responded to Rituxan, another drug made by the same company. In that trial 74 percent responded to treatment with Zevalin, and 15 percent of them achieved a complete remission, meaning there was no evidence of cancer for at least four weeks after treatment. The second study, was a larger comparison trial that randomly assigned 143 patients to treatment with Zevalin or a comparison group treated with Rituxan. Among the 73 patients who received the Zevalin 80 percent responded to treatment compared to56 percent of the 70 patients who received Rituxan alone. More significantly, 30 percent of the Zevalin patients achieved a complete remission compared to only 16 percent of the Rituxan patients. Non-Hodgkin's lymphomas are a group of related cancers that originate in the lymph system and usually spread throughout the body. About 50,000 new cases of all types are diagnosed in the United States each year. It is the fifth most common type of cancer diagnosed in the United States and is increasing as the population ages. The most serious adverse reactions to the Zevalin involved severe infusion reactions including low blood pressure, inflammation and swelling at the infusion site, hypoxia or oxygen deprivation and severe and prolonged suppression of infection-fighting white blood cells and blood-clotting cells. The most common side effects reported were the temporary loss of blood cells and gastrointestinal symptoms such as nausea and vomiting. Among 349 patients treated with Zevalin, 61 percent experienced low platelet (blood clotting cells) counts (thrombocytopenia), and 57 percent experienced low white blood cell counts (neutropenia). IDEC's partner, Schering A.G., Berlin, Germany, which has marketing rights to Zevalin -- outside the United States, had its marketing application for Zevalin accepted for review by the European Medicines Evaluation Agency (EMEA) in January 2001. |
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