The FDA has approved Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) for the treatment of mantle cell lymphoma (MCL) in patients who have received at least one prior therapy.

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Ibrutinib is a small-molecule inhibitor of BTK. Ibrutinib 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 MCL is based on a study where 111 patients were given Imbruvica daily until disease progression or until their side effects became intolerable. Results showed nearly 66 percent of participants had their cancer shrink or disappear after treatment (overall response rate). An improvement in survival or disease-related symptoms has not been established. 

Imbruvica was granted Breakthrough Therapy Designation from the FDA in February 2013 as monotherapy for the treatment of patients with relapsed/refractory MCL and for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p).

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

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