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news.Cell Therapeutics (CTI) has voluntarily withdrawn its new drug application (NDA) for Pixuvri (pixantrone) for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients.
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The NDA was withdrawn as the company required additional time to prepare for the review of the Pixuvri NDA by the FDA’s Oncologic Drugs Advisory Committee (ODAC).
CTI plans to resubmit the Pixuvri NDA in 2012.
Pixuvri is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents.