Amgen closes epratuzumab trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amgen/Immunomedics terminate a single-agent Phase III study of their humanized antibody epratuzumab (AMG 412) in patients with low grade, follicular, B-cell non-Hodgkin's lymphoma who failed other treatments including rituximab (Genentech/IDEC's Rituxan). The firms attribute the closure to approval of new agents that adequately address medical need since the study's September 2001 opening. Idec's radioimmunotherapy Zevalin (ibritumomab) cleared FDA for NHL Feb. 19, 2002. Epratuzumab development will now focus on use in combination with Rituxan for indolent NHL, and use with Rituxan in a chemotherapy setting for aggressive NH
Amgen/Immunomedics terminate a single-agent Phase III study of their humanized antibody epratuzumab (AMG 412) in patients with low grade, follicular, B-cell non-Hodgkin's lymphoma who failed other treatments including rituximab (Genentech/IDEC's Rituxan ). The firms attribute the closure to approval of new agents that adequately address medical need since the study's September 2001 opening. Idec's radioimmunotherapy Zevalin (ibritumomab) cleared FDA for NHL Feb. 19, 2002. Epratuzumab development will now focus on use in combination with Rituxan for indolent NHL, and use with Rituxan in a chemotherapy setting for aggressive NHL |