GlaxoSmithKline and Genmab Submit Arzerra(TM) (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Bl...( Three New Studies Initiated in Other ...),Health

Three New Studies Initiated in Other Oncology Settings

LONDON and COPENHAGEN, Denmark, Jan. 30 /PRNewswire-USNewswire/ -- GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Arzerra(TM) (ofatumumab) to treat patients whose chronic lymphocytic leukemia (CLL) is resistant (refractory) to previous therapies. If approved, ofatumumab would be the first anti-CD20 monoclonal antibody available for this patient population.

CLL is the most common form of adult leukemia in the Western world,(1,2) affecting more than 90,000 Americans.(3) Patients with refractory CLL need new therapies since less than 25 percent respond to most current treatments while still having to cope with adverse effects.(4)

"The submission of the BLA for ofatumumab brings us closer to the possibility of providing a new treatment to patients with refractory CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "This is the first BLA ever filed for an antibody produced by Genmab and is a significant achievement in our partnership with GSK."

The submission is based on an analysis that included 138 patients with 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 tumor masses (>5 cm) in their lymph nodes (bulky fludarabine refractory). The primary endpoint of the study was assessment of response. The overall response rate seen in these patient groups treated with single-agent ofatumumab was 58 percent for the fludarabine alemtuzumab refractory group (n=59) and 47 percent for the bulky fludarabine refractory group (n=79).(5,6)

The most common adverse events (AEs) seen with ofatumumab were re
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