CTI's pixantrone trial for relapsed/refractory aggressive NHL: FDA ODAC finds data inadequate for approval

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration's (the "FDA") Oncologic Drugs Advisory Committee ("ODAC") panel voted unanimously that clinical trial data was not adequate to support approval of pixantrone for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL"). Currently, there are no approved drugs for patients with relapsed or refractory aggressive NHL that have received two or more prior therapies. Pixantrone would be the first drug approved by the FDA for this indication. The FDA is not bound by the recommendations of its advisory committee and the agency is expected to make a decision whether to approve pixantrone for this use by April 23, 2010.

"We continue to believe that pixantrone should be considered as a treatment option for patients with relapsed/refractory aggressive NHL.  There is a significant medical need to bring safe and effective therapies to this very sick patient population," said James A. Bianco, M.D., CEO of CTI. "We are committed to working closely with the FDA to address the committee's comments as quickly as we can."

SOURCE Cell Therapeutics, Inc.