ASH News Daily 2012 - Sunday, December 9, 2012 - (Page C-9)

B:22.5” T:21” S:19” When treated with ARZERRA monotherapy, 42% of patients with CLL refractory to fludarabine and alemtuzumab achieved a partial response Patients had received a median of prior therapies Overall response rate with ARZERRA 60 50 40 30 20 10 The investigator-determined overall response rate in patients with CLL refractory to fludarabine and alemtuzumab was ( CI: , ) There were no complete responses The e ectiveness of ARZERRA is based on the demonstration of durable objective responses No data demonstrate an improvement in disease-related symptoms or increased survival with ARZERRA ( . months—median duration of response CI: . , . ) FLUDARABINE AND ALEMTUZUMAB REFRACTORY (n=59) g), ar of hepatitis B for clinical and laboratory signs of active HBV infection during treatment with ARZERRA and for to months following the last infusion of ARZERRA. Discontinue ARZERRA in patients who develop viral hepatitis or reactivation of viral hepatitis, and institute appropriate treatment. Insu cient data exist regarding the safety of administration of ARZERRA in patients with active hepatitis. Intestinal Obstruction Obstruction of the small intestine can occur in patients receiving ARZERRA. Perform a diagnostic evaluation if obstruction is suspected. Immunizations The safety of immunization with live viral vaccines during or following administration of ARZERRA has not been studied. Do not administer live viral vaccines to patients who have recently received ARZERRA. The ability to generate an immune response to any vaccine following administration of ARZERRA has not been studied. Most Common Adverse Reactions In the pivotal study (total population, n= ) the most common adverse reactions (≥ , all grades) were neutropenia, followed by pneumonia ( ), pyrexia ( ), cough ( ), diarrhea ( ), anemia ( ), fatigue ( ), dyspnea ( ), rash ( ), nausea ( ), bronchitis ( ), and upper respiratory tract infections ( ). ias. , ) ed Most Common Serious Adverse Reactions In the pivotal study (total population, n= ), where ARZERRA was administered at , mg beginning with the second dose for doses, the most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia. A total of patients ( ) experienced bacterial, viral, or fungal infections. A total of patients ( ) experienced ≥Grade infections, of which ( ) were fatal. The proportion of fatal infections in the fludarabine- and alemtuzumab-refractory group was . Please see Brief Summary of Prescribing Information on adjacent pages. How Supplied: Available as different single-use glass vials for dilution and intravenous administration. Each vial contains either mg ofatumumab in mL of solution or , mg ofatumumab in mL of solution. References: . ARZERRA (ofatumumab) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; . . Tam CS, O’Brien S, Lerner S, et al. Leuk Lymph. ; : . cal ed h 

Table of Contents for the Digital Edition of ASH News Daily 2012 - Sunday, December 9, 2012

ASH News Daily 2012 - Sunday, December 9, 2012

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