Dec 01, 2011 - 10:17 am
FDA Approves Removal of Bioscan Requirement for Ibritumomab Tiuxetan (Zevalin)
On November 18, 2011, the U.S. Food and Drug Administration (FDA) removed the pre-treatment bioscan requirement, which changed the existing treatment regimen for ibritumomab tiuxetan (Zevalin). Zevalin is a form of radioimmunotherapy, a cancer therapy that combines a monoclonal antibody with a radioisotope, a source of radiation. Zevalin was first approved by the FDA in February 2002 for the treatment of patients with relapsed or refractory, low-grade, or follicular lymphoma. In September 2009, the FDA also approved Zevalin for previously untreated follicular lymphoma patients who achieved a partial or complete response to first-line chemotherapy.
The removal of the bioscan as part of the treatment regimen has changed the way Zevalin will now be administered to patients. Prior to this, patients received an intravenous infusion of rituximab (Rituxan), which takes several hours, followed by a diagnostic dose of indium-111 Zevalin and a whole body scan at a nuclear imaging center. Over the next several days, two additional whole body images were taken to view the path of the indium-111 Zevalin. Approximately one week after the initial treatment, the patient returned for the second infusion of rituximab followed by the therapeutic portion of Zevalin (the intravenous infusion lasts about 10 minutes). The removal of the bioscan requirement eliminates the diagnostic dose and imaging scans; now patients being treated with Zevalin will receive the two infusions of rituximab followed by Zevalin.
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