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Cell Therapeutics Voluntarily Withdraws Its NDA For Pixuvri - Quick Facts

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
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Cell Therapeutics Inc (CTIC) Monday stated that it has voluntarily withdrawn its New Drug Application, or NDA, for Pixuvri for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.

The company stated that the NDA was withdrawn because, after communications with the U.S. Food and Drug Administration, it needed additional time to prepare for the review of the Pixuvri NDA by the FDA's Oncologic Drugs Advisory Committee at its February 9, 2012 meeting.

The company however stated that it will resubmit the NDA for Pixuvri in 2012.

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