FDA formally rejects CTI's pixantrone

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First, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9-0 against recommending Cell Therapeutics' lead oncology drug pixantrone, and now the FDA has made it official by formally rejecting the pharmaceutical company's application to market pixantrone as a novel treatment for diffuse large B-cell lymphoma (DLBCL) .

The FDA had until April 23 to make its decision but decided not to waste any more time on what amounted to a substandard application and rather poor drug presentation.

By Ross Bonander

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