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Cell Therapeutics hopes to get FDA approval for pixantrone, European Opaxio in '09


SEATTLE Cell Therapeutics announced several goals for 2009 at the JP Morgan Healthcare Conference in San Francisco earlier this week.

The Seattle-based biotech, which specializes in cancer drugs, is hoping to get Food and Drug Administration approval for the compound pixantrone, based on results of a phase 3 extended trial announced in November; the company plans to submit an approval application for the drug during fourth quarter 2009. It also hopes to get approval in Europe for Opaxio, a first-line treatment for patients with non-small cell lung cancer, through a possible commercialization agreement with Novartis. 

It expects the FDA to decide in April whether to approve a supplemental application for Zevalin as a treatment for follicular non-Hodgkin's lymphoma.

"With a focus on cutting-edge oncology drug products, CTI aims to complete its transition from a research-based organization to a leading commercial oncology company," CEO James Bianco said in a statement.

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