FDA ADVISORY PANEL MAKES FAVORABLE RECOMMENDATION FOR GLAXOSMITHKLINE AND GENMAB’S ARZERRA™ (OFATUMUMAB)

GlaxoSmithKline and Genmab today announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 3 that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab

Orlando, FL, USA | May 29, 2009 | GlaxoSmithKline (NYSE: GSK) and Genmab A/S (OMX: GEN) today announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 3 that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.

 

"The committee's positive vote in support of ofatumumab is a potential milestone for patients with CLL. While current initial treatments for CLL can provide prolonged remissions, some patients will progress rapidly and relapse, which highlights the need for new therapies," said Debasish Roychowdhury, M.D., Senior Vice President and Head, Medicines Development, GlaxoSmithKline Oncology. "We look forward to working with the FDA towards an approval for ofatumumab."

 

CLL is the most common form of adult leukemia in the Western world, and the treatment of patients with relapsed disease remains a significant challenge. Patients who have not responded to current standard therapies, or whose disease has returned following prior treatments, typically experience poorer clinical outcomes such as infections and death. Less than 25 percent of CLL patients who are resistant to current treatments respond to available therapies.

 

"The positive vote by ODAC confirms that ofatumumab may offer a new treatment option for patients who have received prior therapies with this type of CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

 

"Today's vote is positive affirmation for this medicine, which is a result of years of dedicated research and collaboration between Genmab and GSK."

 

The advisory committee made its decision based on an interim analysis of a pivotal trial that was presented at the American Society of Hematology 2008 annual meeting and will be presented at the American Society of Clinical Oncology 2009 annual meeting.

 

About CLL

CLL is the most common adult leukemia 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. Based on 2007 worldwide estimates, leukemia (all types) accounted for more than 330,000 new cases and more than 245,000 deaths.

 

CLL cells are malignant B-cells that have a low concentration of CD20 molecules on their surface. B-cells normally protect the body from invading pathogens by developing into plasma cells, which make antibodies. These antibodies directly inactivate pathogens or attach to pathogens to prepare them for destruction by other white blood cells.

 

About ofatumumab

Ofatumumab is an investigational monoclonal antibody that targets a membrane-proximal (close to the cell surface), small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule on B-cells. Ofatumumab also binds to the large loop of the CD20 molecule. The CD20 molecule is a key target in CLL therapy because it is highly expressed in most B-cell malignancies.

 

Ofatumumab is being developed under a collaboration between Genmab and the GSK Oncology and BioPharm R&D Units.

 

Ofatumumab is not yet approved in any country.

SOURCE: Genentech

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