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Lupus Clinical Trials

New Medical Therapies™

Follicular Lymphoma

Patient Medical Areas

October 20, 2008

Cell Therapeutics released positive results from a phase III trial of Zevalin for the treatment of follicular non-Hodgkins lymphoma. This multinational, randomized study, dubbed FIT (First-line Indolent Trial), enrolled 414 subjects with newly diagnosed CD20-positive follicular non-Hodgkins lymphoma who had achieved a partial response or a complete response after receiving a variety of first-line chemotherapy regimens. The FIT trial demonstrated that when used as a first-line consolidation therapy, Zevalin significantly improved the median progression-free survival time from 13.3 months (control arm) to 36.5 months (Zevalin arm) (p<0.0001). This advantage was observed regardless of whether subjects were in partial remission (29.3 versus 6.2 months without Zevalin: p<0.0001) or complete remission (53.9 versus 29.5 months p=0.0154). In addition, 77% of subjects who had achieved only a partial remission after induction therapy were converted to complete remission / complete remission unconfirmed following Zevalin consolidation therapy. Based on the results, a sBLA was submitted to the FDA for use of Zevalin in first-line consolidation therapy.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.