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Re: fohtech post# 4741

Monday, 03/22/2010 12:00:57 PM

Monday, March 22, 2010 12:00:57 PM

Post# of 7234
US panel rejects Cell Therapeutics lymphoma drug:

Mon Mar 22, 2010 11:55am EDT

* Panel votes 9-0 that company trial was inadequate

* FDA usually follows panel recommendations

GAITHERSBURG, Md., March 22 (Reuters) - Cell Therapeutics Inc (CTIC.O) has not collected enough data on an experimental lymphoma drug to win U.S. approval, a government advisory panel unanimously said on Monday.

Advisers to the Food and Drug Administration, in a 9-0 vote, said the company's single trial was not adequate to support approval of the drug, pixantrone.

Seattle-based Cell Therapeutics is seeking FDA clearance to sell pixantrone under the name Pixuvri for treating non-Hodgkin's lymphoma that has stopped responding to other treatments.

The final decision rests with the FDA, but the agency usually follows panel recommendations. An FDA ruling is due by April 23.

Cell Therapeutics' shares were halted on Nasdaq while the panel met. (Reporting by Lisa Richwine, editing by Maureen Bavdek)

http://www.reuters.com/article/idUKN2218931820100322?rpc=44


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