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| Site Navigation | Monoclonal Antibody Therapy: Zevalin |
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| ZevalinÔ
(Ibritumomab tiuxetan) is a radiolabeled monoclonal
antibody for B-cell lymphomas - the first to
be approved for human use by the US Food and Drug Administration (US FDA
approval granted February 19, 2002). It is manufactured in the US by IDEC
Pharmaceuticals. It is licensed to Schering AG, Germany for
worldwide marketing & distribution outside the US. Schering received
European approval for Zevalin® on January 22, 2004. How it works: Radioimmunotherapy Radioimmunotherapy is a promising new area of cancer treatment that combines the targeting power of monoclonal antibodies with the cell-damaging ability of localized radiation. Radioimmunotherapies like Zevalin are made by linking monoclonal antibodies – engineered in a laboratory to recognize and attach to substances on the surface of certain cells – to radioactive isotopes. When infused into a patient, these radiation-carrying antibodies circulate in the body until they locate and bind to the surface of specific cells, and then deliver their cytotoxic radiation directly to the cancerous cells. Zevalin comes with two types of radiolabeling: One with Indium-111 (In-111) and one with Yttrium-90 (Y-90). Both are used in conjunction with Rituxan in a treatment plan. Response 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 a relapsed or refractory patient population was based on overall response rates (ORR). The first efficacy study, on which the full approval is based, was conducted in 54 patients with relapsed follicular lymphoma who no longer adequately responded to Rituxan, 74 percent showed an ORR to treatment with Zevalin, with 15 percent of patients achieving a complete remission (CR) to therapy, according to the International Workshop Response Criteria (IWRC). The second study, a Phase III randomized, controlled trial, which supports accelerated approval, was conducted in 143 patients with relapsed or refractory, low grade or follicular NHL or transformed B-cell NHL. The 73 patients who received the Zevalin therapeutic regimen showed an ORR of 80 percent, compared to 56 percent in 70 patients who received Rituxan alone, according to the IWRC. Thirty percent (30%) of Zevalin patients achieved a complete remission (CR) and four percent (4%) achieved an unconfirmed complete remission (CRu) to therapy, compared to sixteen percent (16%) of Rituxan patients who achieved a complete remission and four percent (4%) who achieved an unconfirmed complete remission, according to the IWRC. Side Effects The primary side effect associated with Zevalin during clinical trials was reduction in blood-cell counts as a result of myelosuppression (decreased blood-cell production by the bone marrow). Patients more likely to experience this were those with bone marrow involvement in lymphoma or with significant bone marrow damage from prior therapy. Decreased blood counts resulted in hospitalizations for infection or febrile neutropenia (a decrease in the number of neutrophils, a type of white blood cell that fights infection, in the blood) in 7 percent of patients, and life-threatening bleeding in less than 1 percent. The non-hematologic (non-blood-related) side effects experienced by patients in the trials were generally mild and reversible. These side effects included infusion-related reactions, such as chills, fever, throat irritation and nausea, and are consistent with those seen with Rituxan (Rituximab monoclonal antibody) as single-agent therapy. Severe infections (predominately bacterial in origin) and hemorrhage, including fatal cerebral hemorrhage, have occurred in a minority of patients in clinical studies. Also seen were myeloid malignancies and dyscrasias (myelodysplastic syndrome). The most common toxicities reported were neutropenia, thrombocytopenia, anemia, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), increased cough, dyspnea, dizziness, arthralgia, anorexia and ecchymosis Manufacturer / More Information:
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