FDA Removes Bioscan Requirement for Zevalin

Spectrum announced that the FDA has approved the removal of the pre-treatment biodistribution evaluation requirement using Indium-111 Zevalin (radionuclide [B-lymphocyte-restricted differentiation antigen (CD20) inhibitor]) imaging dose followed by a gamma scan before administering the Zevalin therapeutic dose. Prior to the removal of the bioscan requirement, patients received an infusion of rituximab on Day 1, followed by a diagnostic dose of radiolabeled Indium-111 Zevalin and a full-body scan at a nuclear imaging center within ten minutes and again on Day 3 or 4. Patients would then receive another infusion of rituximab and a 10-minute injection of the therapeutic dose of Zevalin on Day 7, 8, or 9.

Following the bioscan requirement removal, patients undergoing treatment with Zevalin will now receive the two infusions of rituximab followed by a 10-minute injection of Zevalin. This simplified regimen will now be called “RRZ” – rituximab, rituximab, Zevalin.

Zevalin, a CD20-directed radiotherapeutic antibody, is indicated for the treatment of B-cell non-Hodgkin's lymphoma (relapsed or refractory, low grade or follicular) and previously untreated follicular non-Hodgkin's lymphoma in patients who achieve a partial or complete response to first-line chemotherapy.

For more information call (877) 387-4538 or visit www.zevalin.com.