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.