ODAC review rescheduled for CTI's pixantrone
Seattle-based Cell Therapeutics (CTI) announced today that their rescheduled day of reckoning will now be on March 22, 2010. This is the day when the FDA's Oncologic Drugs Advisory Committee (ODAC) will meet to properly review CTI's new drug application for pixantrone as a treatment for diffuse large B-cell lymphoma (DLBCL).
This review should have taken place back in February but was postponed by bad weather.
The Oncologic Drugs Advisory Committee is an independent panel of experts which evaluates the performance of cancer drugs and, based on that evaluation, makes recommendations to the FDA regarding approval or rejection.
The FDA has final approval and is not beholden to the recommendation of the ODAC. The agency is scheduled to announce its final decision regarding pixantrone on April 23, 2010.
Information on pixantrone from Cell Therapeutics
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