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GlaxoSmithKline and Genmab Submit Arzerra(TM) (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer
Date:1/30/2009

lated to infusion reactions and infections. AEs seen in at least 10 percent of patients included fever, cough, diarrhea, rash, low white blood cell counts, fatigue, pneumonia, anemia, shortness of breath and nausea. In clinical trials to date, infusion reactions that were serious yet manageable were seen in three percent of patients. One case of progressive multifocal leukoencephalopathy (PML), a rare brain infection resulting in death or causing severe disability, and one case of tumor lysis syndrome were reported.(5,6) These data were presented at the 50th Annual Meeting of the American Society of Hematology (ASH) in December 2008.

Potential to Combat CLL in Earlier Stages

The companies also announced today the initiation of an additional Phase III study of ofatumumab in combination with fludarabine and cyclophosphamide (FC) for patients with CLL when initial treatment no longer works (second-line treatment). The open-label study will randomize 352 patients to evaluate progression-free survival (PFS) of ofatumumab in combination with FC therapy versus FC therapy alone for the treatment of relapsed CLL.(7) Enrollment for this study will begin shortly.

"Bolstered by the positive results of ofatumumab for advanced stage CLL, we're now investigating ofatumumab in earlier stages in the treatment continuum," said Paolo Paoletti, M.D., Senior Vice President of Oncology R&D, GSK. "The clues we're seeing from ofatumumab also suggest possible activity in other oncology settings, which we're currently evaluating through several clinical trials."

GSK and Genmab will conduct additional studies of ofatumumab in CLL and non-Hodgkin's lymphoma (NHL) settings. In CLL, a Phase III front-line study is evaluating ofatumumab combined with chlorambucil in patients with previously untreated CLL. In NHL, an ongoing Phase II study will assess ofatumumab in patients with Waldenstrom's Macroglobulinemia - a rare type of
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SOURCE GlaxoSmithKline
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