Ibrutinib for CLL
Ibrutinib is a new drug that was recently approved for Mantle Cell Lymphoma. 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. While it was approved for Mantle Cell Lymphoma, the application for CL is still being considered. Most recently, in January of 2014, Lancet published a positive study in elderly patients with CLL and FDA approval for CLL is widely anticipated.
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