Mar 2 2010
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee ("ODAC") will review CTI's New Drug Application ("NDA") for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL") on March 22, 2010. The meeting was to take place on February 10, 2010, but the FDA postponed the meeting because of severe weather conditions in the Washington, D.C. area. Following the vote at the rescheduled ODAC meeting, the FDA is expected to make a final decision on approval of CTI's NDA for pixantrone by April 23, 2010.
"Our team is well-prepared to deliver an evidenced-based presentation to the ODAC panel, which we expect will provide a persuasive argument to the clinicians on the panel for the approval of pixantrone," said James A. Bianco, M.D., CEO of CTI. "The ODAC meeting is an important milestone in the review process, and we look forward to discussing the efficacy and safety data for pixantrone with the members of the panel and the FDA review team." Dr. Owen O'Connor, Chief of Hematology Oncology at NYU Cancer Institute, and Dr. John Leonard, Chief of Lymphoma Myeloma at Weill Corner Cancer Center will be presenting on behalf of CTI.
ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. The FDA regulations indicate that although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA.
SOURCE Cell Therapeutics, Inc.