The US Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) to treat chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab.
The drug was approved under the FDA’s accelerated approval process,
which allows drugs that meet unmet medical needs to be approved faster.
Accelerated approval is based on a surrogate endpoint; for example, a
reduction in tumor, spleen, or lymph node size.
These indicators provide reasonable evidence that the drug will allow patients to live longer with fewer disease-related side effects.
However, accelerated approval requires studies of the drug to continue.
Currently, the manufacturer, Genmab, is conducting a clinical trial to confirm that adding ofatumumab to standard chemotherapy delays the progression of CLL.
Side effects from previous studies include pneumonia, fever, cough, diarrhea, fatigue, shortness of breath, rash, nausea, bronchitis, upper respiratory tract infection, lower red blood cell count, and a decrease in normal white blood cells.
Increased risk of infection is the most serious risk, including progressive multifocal leukoencephalopathy. Patients at high risk for hepatitis B should be tested before using ofatumumab.
Researchers have also investigated other uses for ofatumumab, including the treatment of rheumatoid arthritis, in which it appeared to be safe and effective.
