New Leukemia Rx Gets FDA Nod

Ofatumumab approved for extended treatment of chronic lymphocytic leukemia patients

(RxWiki News) Doctors may now have another tool in their arsenal for the treatment of chronic lymphocytic leukemia (CLL).

This week, the US Food and Drug Administration (FDA) approved the injection drug ofatumumab (brand name Arzerra) for patients with CLL. This drug is approved to treat patients in complete or partial response after at least two prior CLL treatments.

CLL is a type of cancer in which the bone marrow makes excess lymphocytes (a type of white blood cell). CLL typically progresses more slowly than other types of leukemia and tends to affect older adults. Over time, CLL can spread to other parts of the body, including the lymph nodes, liver and spleen.

Each year in the US, about 16,000 people are diagnosed and about 4,400 people die from the disease.

Ofatumumab is what's known as a monoclonal antibody. Antibodies are produced by the immune system in response to invaders. Ofatumumab works to make cancer cells more susceptible to immune system attack.

Ofatumumab was previously approved to treat previously untreated CLL patients for whom fludarabine-based treatment is considered inappropriate and for those whose cancer did not improve with fludarabine (Fludara) or alemtuzumab (Lemtrada).

The new approval was based on a trial of 474 CLL patients with an average age of 64. These patients were randomly assigned to ofatumumab or no treatment for an average of 15 months. The median progression-free survival (PFS) was 29.4 months for those who received ofatumumab and 15.2 months for the other group.

The most common side effects reported were reactions at the injection site, abnormal white blood cell count and upper respiratory tract infections. About 33 percent of patients reported serious reactions, including pneumonia and fever.

The recommended dose for ofatumumab is 300 milligrams by injection on day 1, followed by 1,000 mg on day 8 and seven weeks later, and then every eight weeks thereafter for up to two years.

Review Date: 
January 19, 2016