FDA posts Arzerra briefing documents

FDA posted briefing documents ahead of Friday's Oncologic Drugs Advisory Committee meeting to discuss a BLA for Arzerra ofatumumab from Genmab A/S (CSE:GEN) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). The companies are seeking accelerated approval of Arzerra as a single agent to treat patients with chronic lymphocytic leukemia (CLL). The committee will be asked to discuss whether the objective response rate (ORR) observed in the Phase III Hx-CD20-406 trial is of sufficient magnitude to be "reasonably likely to predict clinical benefit."

The BLA is based on interim data from the open-label, single-arm, international Hx-CD20-406 trial. Primary efficacy data were derived from a subgroup of 59 CLL patients who were double refractory to fludarabine and alemtuzumab. The study also included 79 patients refractory only to fludarabine, but FDA said only the double refractory population represented an unmet need. The agency said the companies would need to conduct a comparative study to support approval in a patient population refractory to one drug. Genzyme Corp. (NASDAQ:GENZ) and Bayer AG (Xetra:BAY) market Campath/ MabCampath alemtuzumab. ...