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Imbruvica Approval History

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström’s macroglobulinemia.

Development History and FDA Approval Process for Imbruvica

Mar  4, 2016Approval FDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia
Jan 29, 2015Approval FDA Expands Approved Use of Imbruvica for Waldenström’s Macroglobulinemia
Jul 28, 2014Approval FDA Expands Approved Use of Imbruvica for Chronic Lymphocytic Leukemia
Feb 12, 2014Approval FDA Approves Imbruvica to Treat Chronic Lymphocytic Leukemia
Nov 13, 2013Approval FDA Approves Imbruvica for Mantle Cell Lymphoma
Aug 29, 2013New Drug Application Filing for Ibrutinib Accepted in Two B-cell Malignancies by the U.S. FDA
Jul 10, 2013New Drug Application Submitted to U.S. FDA for Ibrutinib in the Treatment of Two B-Cell Malignancies

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