US Pharm. 2009;34(11):24.
The FDA approved ofatumumab (Arzerra) for treating patients with chronic lymphocytic leukemia (CLL), a blood and bone marrow cancer. Ofatumumab was approved using the accelerated approval process for patients with CLL whose cancer is uncontrolled by other types of chemotherapy. The effectiveness of the drug was evaluated in 59 patients with CLL whose disease no longer responded to the available therapies. CLL, which arises from B cells found in the body's immune system, mainly afflicts patients older than 50 years, killing about 4,400 people each year.
"The approval of Arzerra illustrates FDA's commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options," said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. The manufacturer, GlaxoSmithKline, is currently conducting a clinical trial to verify that ofatumumab added to standard chemotherapy delays CLL progression.