FDA's ODAC to Review Resubmitted Pixantrone NDA on February 9, 2012
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Cell Therapeutics, Inc. (CTI) has announced that on February 9, 2012 the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review CTI's resubmitted New Drug Application (NDA) for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy.
ODAC is a 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 recommendations to the FDA.
The FDA will consider the recommendation of the panel, but the final decision regarding the approval of the product is made by the FDA.
"We are pleased the Office of Oncology Drug Products (OODP) chose to bring our pixantrone NDA back to ODAC for review now that we have provided additional information and data recommended by the Office of New Drugs (OND) that we believe addresses the issues raised in the OODP Complete Response Letter of April 2010," stated James A. Bianco, CEO of CTI.
Bianco continued, "We believe the NDA demonstrates that pixantrone has a favorable benefit risk profile compared to standard chemotherapy in patients with relapsed or refractory aggressive NHL, a patient population for which there are no approved agents."
