Cell Therapeutics' Pixuvri turned down by FDA for non-Hodgkin's lymphoma
This article was originally published in Scrip
Executive Summary
Cell Therapeutics' NDA for its lead drug candidate Pixuvri (pixantrone dimaleate) to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) has been turned down by the US FDA.The agency has recommended the company conduct an additional trial to demonstrate the safety and efficacy of the chemotherapeutic agent.