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Cell Therapeutics pulls Pixuvri filing for non-Hodgkin's lymphoma

Additional time needed to prepare for FDA review

Cell Therapeutics Inc (CTI) has withdrawn its marketing application of non-Hodgkin's lymphoma (NHL) drug candidate Pixuri (pixantrone) in the US after the Food and Drug Administration (FDA) denied additional time to prepare for an advisory committee meeting.

Shares in the company fell on the announcement, which marks the second failure by CTI to guide Pixuvri through the US registration process.

In 2010, the FDA rejected a first application for the drug on the grounds that an additional clinical trial was needed to demonstrate Pixuvri's safety and effectiveness.

If approved, Pixuvri would be used as a last-line treatment for aggressive NHL that no longer responds to other therapies.

The company said it withdrew its New Drug Application (NDA) because it needed additional time to prepare for the review of the Pixuvri NDA by the agency's Oncologic Drugs Advisory Committee (ODAC), scheduled to take place on February 9.

It had requested deferral to a date in late March.

The FDA action date for the NDA was April 24, and CTI said it had no option given the timeframe of withdrawing the application with a view to refilling it later in 2012. The timescale for re-filing and reviewing the dossier looks set to delay the programme by up to 18 months.

In Europe, CTI submitted a marketing application for pixantrone in 2010 and is still going through the registration process.

In the latter half of 2011 the company submitted additional data to the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) and now hopes to hear a verdict on the application sometime later this quarter.

CTI still has no products on the market, and in its third-quarter 2011 results statement indicated that it had about $50m in cash reserves. It has been using up its capital reserves at a rate of about $15m a quarter.

31st January 2012

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