Cell Therapeutics Inc. announced Monday that it has voluntarily withdrawn its application for cancer drug Pixuvri. According to Reuters, the company said it needed more time to prepare for the review of the pill.
Cell Therapeutics first attempted to have the U.S. Food and Drug Administration simply reschedule the drug’s review, but the agency was unable to comply and the company now plans to resubmit the application later in the year.
According to TheStreet.com, the withdrawal was an unexpected move for Cell Therapeutics, which had already suffered a setback in the drug’s development. Pixuvri was first rejected by the FDA in March 2010 when an advisory panel voted 12-0 to recommend rejection. The company appealed the rejection and resubmitted the drug last year.
Pixuvri was scheduled to be reviewed on April 24, TheStreet said. CEO Jim Bianco had reportedly been expecting a positive review.
Pixuvri is intended to treat patients with relapsed or refractory aggressive non-Hodgkin’s lymphoma. It would be especially marketed toward patients who had tried previous therapy two or more times without receiving any benefit.
Shares of the Seattle-based company fell 17 percent on the news, hitting $1.13 in premarket trade. They had previously closed at $1.33 on Friday, Reuters said.
