The FDA has expanded the use of Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) for patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy. Imbruvica was approved in November 2013 for the treatment of mantle cell lymphoma (MCL) in patients who have received at least one prior therapy.

Imbruvica is a small-molecule inhibitor of BTK that forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. Nonclinical studies have shown that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.

The FDA’s accelerated approval for CLL is based on a clinical study of 48 previously treated patients that received Imbruvica 420mg until they reached unacceptable toxicity or disease progression. Study results showed that 58% of patients had their cancer shrink after treatment (overall response rate). The duration of response also ranged from 5.6–24.2 months. However, an improvement in survival or disease-related symptoms has not been established.

Imbruvica is available as 140mg capsules in 90- and 120-count bottles.

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