FDAnews Drug Daily Bulletin

GlaxoSmithKline and Genmab’s Arzerra (ofatumumab) should be available for prescription use this month. The monoclonal antibody, which had accelerated approval, is indicated to treat patients with chronic lymphocytic leukemia that is resistant to fludarabine and alemtuzumab, the standard treatment options. Patients at high risk for hepatitis B should be screened before receiving the drug, and those with inactive hepatitis should be monitored for reactivation of the infection during and following treatment, the FDA says.
Washington Drug Letter