The US Food and Drug Administration approved ofatumumab (Arzerra) for patients with chronic lymphocytic leukemia (CLL) whose cancer is no longer being controlled by other forms of chemotherapy. The product was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs.
“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 accelerated approval process requires further study of the drug. The manufacturer is currently conducting a clinical trial in CLL patients to confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease.
Safety and Effectiveness
Ofatumumab’s effectiveness was evaluated in 59 patients with CLL whose disease no longer responded to the available therapies. The product’s safety was evaluated in 181 patients in two studies in patients with cancer. Common side effects included a decrease in normal white blood cells, pneumonia, fever, cough, diarrhea, lower red blood cell counts, fatigue, shortness of breath, rash, nausea, bronchitis and upper respiratory tract infections.