GlaxoSmithKline and Genmab A/S announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the Arzerra (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukaemia (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, 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 leukaemia 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 per cent 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," saidLisa N Drakeman, chief executive officer of Genmab. "The 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 Haematology 2008 annual meeting and will be presented at the American Society of Clinical Oncology 2009 annual meeting.
Ofatumumabis 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.