FDA announces expanded approval of Arzerra in combination with chlorambucil for CLL treatment

The US Food and Drug Administration has announced the expanded approval of Arzerra^® (ofatumumab) in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukemia (CLL). Arzerra^® was previously approved by the FDA in October 2009 for the treatment of CLL resistant to other forms of chemotherapy. Diplomat has access to dispense Arzerra^®.

In the clinical trials results were evaluated based on progression free survival (PFS), which is the length of time a patient lives with a disease but it does not worsen. Arzerra^® in combination with chlorambucil showed an average PFS of 22.4 months as compared to an average PFS of 13.1 months in patients receiving chlorambucil alone.

According to the American Cancer Society, CLL accounts for approximately one-third of new leukemia cases in adults. The average age at diagnosis is 72 years and is considered extremely rare in patients under the age of 40.

The most common adverse reactions to Arzerra^® were related to the administration of the drug via infusion and were considered to be Grade 2 or lower. The most common adverse reactions unrelated to the infusion process were neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory infection, arthralagia and upper abdominal pain.  

Arzerra^® is manufactured by GLAXO GROUP LIMITED and distributed by Glaxo Smith Kline.