CTI shuns FDA advice over new pixantrone trial
This article was originally published in Scrip
Executive Summary
Cell Therapeutics (CTI) has gone against the US FDA's advice on the design of a new trial that it has just started for its lead chemotherapeutic, pixantrone, even though it hopes the study could serve as a follow-on pivotal trial if the agency remains firm on its April 2010 decision to reject the product's NDA for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).