GSK and Genmab have received approval of Arzerra (ofatumumab) from the FDA for use in patients with chronic lymphocytic leukemia (CLL) that do not respond to fludarabine and alemtuzumab. Arzerra is a monoclonal antibody that causes the body’s immune response to fight against normal and cancerous B-cells.

The approval is based on results from a study in which 42% of patients with CLL, who did not respond to both fludarabine and alemtuzumab (two therapies used in treating CLL), responded to treatment with Arzerra. These patients had a median duration of response of 6.5 months. The most common adverse reactions were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions seen were infections (including pneumonia and sepsis), neutropenia, and pyrexia.

“The approval of Arzerra brings an important new treatment option to patients with refractory CLL,” said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. “This approval also marks a key milestone for Genmab as it is our first antibody to reach the market. All of us involved in the development of Arzerra are pleased that we have been able to move the product so quickly through research and development and meet our goal of providing this innovative therapy to patients.”

“Arzerra is a significant step forward in helping patients and physicians better manage the challenges of refractory CLL. Patients now have a new choice,” said Kathy Rouan, Ph.D., vice president and medicines development leader at GlaxoSmithKline. “The Arzerra approval demonstrates the commitment of the GSK BioPharm and Oncology Units to developing new biopharmaceutical treatment options for cancer patients.”