ARTICLE | Clinical News

Pixantrone regulatory update

September 20, 2010 7:00 AM UTC

Cell Therapeutics said it plans to start the formal dispute resolution process to appeal an April complete response letter for an NDA for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma. The company said there are no approved or effective therapies for the indication beyond second relapse and that after discussing data from its Phase III PIX301 trial in NHL with lymphoma experts and biostatisticians, it believes pixantrone has already met FDA's requirements for accelerated approval. The company expects a decision on the appeal next quarter. ...