GSK’s Arzerra Wins FDA Recommendation

31 May 2009 (Last Updated May 31st, 2009 18:30)

The FDA's Oncologic Drugs Advisory Committee in the US has voted ten to three to recommend GlaxoSmithKline (GSK) and Genmab's Arzerra (ofatumumab). The FDA believes that testing data is likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL), whose disease

The FDA's Oncologic Drugs Advisory Committee in the US has voted ten to three to recommend GlaxoSmithKline (GSK) and Genmab's Arzerra (ofatumumab).

The FDA believes that testing data is likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL), whose disease is refractory to fludarabine and alemtuzumab.

GSK oncology senior vice president and head of medicines development Debasish Roychowdhury said that 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 Roychowdhury.

"We look forward to working with the FDA towards an approval for ofatumumab."