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news.GlaxoSmithKline, or GSK, and Genmab have submitted a biologics license application to the FDA for Arzerra to treat patients whose chronic lymphocytic leukemia is resistant to previous therapies. If approved, ofatumumab would be the first anti-CD20 monoclonal antibody available for this patient population, said GSK.
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The submission is based on an analysis that included 138 patients with chronic lymphocytic leukemia (CLL) who showed limited or no response to both fludarabine and alemtuzumab treatment (fludarabine alemtuzumab refractory) and patients who were refractory to fludarabine and considered inappropriate candidates for alemtuzumab due to bulky tumour masses (>5cm) in their lymph nodes (bulky fludarabine refractory). The primary endpoint of the study was assessment of response.
The companies also initiated 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 of ofatumumab in combination with FC therapy versus FC therapy alone for the treatment of relapsed CLL. Enrollment for this study will begin shortly.
Lisa Drakeman, CEO of Genmab, said: “The submission of the biologics license application (BLA) for ofatumumab brings us closer to the possibility of providing a new treatment to patients with refractory CLL. This is the first BLA ever filed for an antibody produced by Genmab and is a significant achievement in our partnership with GSK.”