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June 16, 2009

GSK’s Azerra Review Extended

GlaxoSmithKline (GSK) and Genmab's chronic lymphocytic leukaemia (CLL) drug Azerra (ofatumumab) has been granted a three-month Biological Licence Application (BLA) action date extension by the US Food and Drug Administration (FDA). The BLA was submitted on 30 January 2009 and was granted

By cms admin

GlaxoSmithKline (GSK) and Genmab’s chronic lymphocytic leukaemia (CLL) drug Azerra (ofatumumab) has been granted a three-month Biological Licence Application (BLA) action date extension by the US Food and Drug Administration (FDA).

The BLA was submitted on 30 January 2009 and was granted priority review by the FDA. The three-month extension will allow the agency to review additional chemistry and manufacturing data submitted on 5 June. The new action date for the BLA is 31 October 2009.

The FDA Oncology Drugs Advisory Committee ruled that trial data of ofatumumab showed that it was likely to offer clinical benefit for certain patients with CLL.

CLL is the most common adult leukaemia and one of the most common malignant lymphoid diseases.

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