Biogen Idec galiximab starts Phase III
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Biogen Idec has initiated a Phase III trial of its anti-CD80 monoclonal antibody galiximab for follicular non-Hodgkin's lymphoma. The TARGET trial (Targeted Antibody Therapy with Rituxan and Galiximab Efficacy Trial ) will compare treatment with galiximab in combination with Genentech/Biogen Idec's Rituxan (rituximab) in patients with follicular NHL who have relapsed or failed to respond to initial therapy. Conducted under a special protocol assessment, the trial enrolled its first patient in November 2006, and will enroll roughly 700 patients at more than 150 centers worldwide. Progression-free survival is the primary endpoint. The company told Pharmaceutical Approvals Monthly that it hopes to file the galiximab BLA for follicular NHL by mid-2010...