Action Date for Ofatumumab BLA Extended by Three Months

Action Date for Ofatumumab BLA Extended by Three Months

The U.S. Food and Drug Administration (FDA) has extended the action date for review of the biologics license application (BLA) of GlaxoSmithKline and Genmab A/Ss investigative agent ofatumumab by three months.

Submission of the BLA for ofatumumab was submitted January 2009 and was granted priority review by the FDA.  Additional chemistry and manufacturing data were submitted to the FDA on June 5, 2009. The three-month extension of the action date will allow the FDA to review the additional data.

Ofatumumab is a fully human antibody that is being developed for chronic lymphocytic leukemia (CLL). An FDA Oncology Drugs Advisory Committee (ODAC) held a meeting in May 2009 and voted 10-3 that ofatumumab was likely to offer clinical benefit for some patients with CLL.

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