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news.GlaxoSmithKline and Genmab have announced that FDA's Oncologic Drugs Advisory Committee (ODAC) has voted ten to three 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.
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Debasish Roychowdhury, Senior Vice President and Head of Medicines Development at GlaxoSmithKline Oncology, said: 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,
“We look forward to working with the FDA towards an approval for ofatumumab, he added.