Learn more about other FDA Approvals for CLL here.

Find more information on CLL here.

The US Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib) for first-line use in patients with chronic lymphocytic leukemia (CLL). The approval means that there is, for the first time, a chemotherapy-free option for initial treatment of CLL.1

Chronic lymphocytic leukemia is the most common form of adult leukemia. The American Cancer Society estimates that approximately 15,000 people will be diagnosed with CLL this year. Currently, there are approximately 95,000 people in the United States living with CLL.

CLL is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells that exist in two forms: B- and T-cells. These cells are produced in the bone marrow and each serves a specific function in aiding the body to fight infection. The large majority of CLL cases involve mature B-lymphocytes that tend to live much longer than normal. B-lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. This results in overcrowding of these areas and suppression of the formation and function of blood and immune cells. Additionally, the cancerous lymphocytes themselves do not function normally, leading to a further reduction in the body’s ability to fight infection.

CLL is diagnosed most commonly in elderly patients (65 years or greater). Since these patients are often unable to tolerate the aggressive therapies compared to their younger counterparts due to additional medical conditions and/or differences in the metabolizing of the agents, the toxicity of treatment is an important issue.

Imbruvica is a first-in-class oral, covalent inhibitor of Bruton’s tyrosine kinase. The drug has already been approved for use in patients with pretreated CLL, and in CLL patients with the del17p mutation (including as initial treatment).

The approval of Imbruvica was made on the basis of results from the RESONATE-2 trial, which showed that Imbruvica was superior to chlorambucil in 269 older treatment-naive patients with CLL or small lymphocytic lymphoma.2


  1. IMBRUVICA Prescribing Information, March 2016.Burger J, Tedeschi A, Barr P, et al. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015;373:2425-2437.

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