FDA extends review of Arzerra™ (ofatumumab)

Issued: Tuesday 16 June 2009, London UK

GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has extended the action date for the ofatumumab BLA application by three months. 

The BLA was submitted on 30 January 2009 and was granted priority review by the FDA.  Under priority review, the FDA sets the target date for a decision at six months, rather than the standard 10 month review.  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.

An FDA Oncology Drugs Advisory Committee (ODAC) held on 29 May 2009, voted 10-3 that ofatumumab was likely to offer clinical benefit for certain patients with chronic lymphocytic leukaemia (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.

CLL is the most common adult leukaemia and one of the most common malignant lymphoid diseases. In the United States, about 90,000 people are living with CLL, with approximately 15,000 estimated new cases being diagnosed in 2009.

GSK and Genmab are committed to working with the FDA in order to bring this potential new treatment option to patients. 

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.

Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.  Genmab’s world class discovery, development, and manufacturing teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options.  For more information on Genmab’s products and technology, visit www.genmab.com.