Ibrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor. The effectiveness and safety of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies. There is evidence that it is effective for CLL.
A New Drug Application for ibrutinib was submitted to the U.S. Food and Drug Administration (FDA) for its use in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and for its use in the treatment of previously treated patients with mantle cell lymphoma (MCL). The submission is supported by data from two pivotal Phase 2 studies, one in relapsed/refractory CLL/SLL (PCYC-1102) and one in relapsed/refractory MCL (PCYC-1104), both of which were published in The New England Journal of Medicine online on June 19, 2013. Most recently, in January of 2014, Lancet published a positive study in elderly patients with CLL And FFA approval for CLL ws then granted. As of 2014, this drug is FDA approved for both Mantle Cell Lymphoma and CLL. It was also recently approved for Waldenstrom’s Macroglbulinemia. For CLL, IMBRUVICA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior and IMBRUVICA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion.
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Prof Susan O’Brien MD,Richard R Furman MD,Prof Steven E Coutre MD,Jeff P Sharman MDnet al, Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial The Lancet Oncology – 1 January 2014 ( Vol. 15, Issue 1, Pages 48-58
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