FDA Sets Action Date For Review Of Pixantrone NDA

The FDA has notified Cell Therapeutics (CTI) that a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 under standard review, has been established regarding CTI’s NDA for pixantrone.

Pixantrone is said to be a potential treatment for relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL). Additionally, Pixantrone has fast track designation for the relapsed / refractory aggressive NHL application.

Based on the user fee goal date, if pixantrone is approved, CTI estimates that pixantrone could be available to patients in the US early in the second quarter of 2010.

CTI, use genomic information to develop a personalized approach to cancer therapy with the goal of making standard-of-care treatment less toxic and more effective for individual patients.