Arzerra® Plus Chlorambucil Approved for Newly Diagnosed Leukemia

The United States Food and Drug Administration (FDA) has recently approved the treatment combination of Arzerra (ofatumumab) and chlorambucil for patients with chronic lymphocytic leukemia (CLL). The approval indication states that patients with CLL must have not received prior therapy, and are not candidates for fludarabine (Fludara)-based therapy.

Chronic lymphocytic leukemia is a common type of leukemia that typically affects individuals ages 65 and older. Often, CLL starts as a slow-growing disease, and then progresses to a more aggressive form. It originates in immune cells referred to as B-lymphocytes.

Fortunately, there are several treatment options for CLL, several of which are targeted therapeutic approaches.

Arzerra is a type of therapy that targets the CD20 protein, which is on the outside of B-lymphocyte cells. Arzerra attaches to the CD20 protein and kills the B-lymphocyte to which it is bound. Chlorambucil is a type of chemotherapy agent that is often used in the treatment of CLL.

The approval of the Arzerra/chlorambucil combination was based on results from a trial including 447 patients with newly diagnosed CLL. These patients were not eligible for fludarabine-based treatment (fludarabine is a commonly used chemotherapy agent in CLL), either due to advanced age or other medical conditions.

The median time of survival without progression of cancer was 22.4 months for those treated with Arzerra/chlorambucil, compared with only 13.1 months for those treated with chlorambucil only.
Side effects were more common among those treated with Arzerra/chlorambucil, particularly with infusion reactions.
Reference: United States Food and Drug Administration (FDA). Ofatumumab. Accessed May 8, 2014. Available at: