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FDA Extends Review of Ofatumumab

FDA Extends Review of Ofatumumab

The US Food and Drug Administration (FDA) has extended the action date for a biological licensing application (BLA) application for ofatumumab (Arzerra) by 3 months. The BLA was submitted on January 30, 2009 and was granted priority review by the FDA. Under priority review, the FDA sets the target date for a decision at 6 months, rather than the standard 10-month review. The 3-month extension allows the agency to review additional chemistry and manufacturing data submitted on June 5. The new action date for the BLA is October 31, 2009.

An FDA Oncology Drugs Advisory Committee (ODAC), held on May 29, 2009, voted 10 to 3 that ofatumumab was likely to offer clinical benefit for certain patients with chronic lymphocytic leukemia (CLL). Data from the pivotal trial of ofatumumab were presented at the American Society of Hematology 2008 annual meeting and at the American Society of Clinical Oncology 2009 annual meeting.

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