Imbruvica Approval History
Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, small lymphocytic lymphoma, marginal zone lymphoma, and chronic graft versus host disease.
Development History and FDA Approval Process for Imbruvica
Date | Article |
---|
Aug 2, 2017 | FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease |
Jan 19, 2017 | U.S. FDA Approves Imbruvica (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) |
May 9, 2016 | U.S. FDA Expands Imbruvica (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients |
Mar 4, 2016 | FDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia |
Jan 29, 2015 | FDA Expands Approved Use of Imbruvica (ibrutinib) for Waldenström’s Macroglobulinemia |
Jul 28, 2014 | FDA Expands Approved Use of Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia |
Feb 12, 2014 | FDA Approves Imbruvica (ibrutinib) to Treat Chronic Lymphocytic Leukemia |
Nov 13, 2013 | FDA Approves Imbruvica (ibrutinib) for Mantle Cell Lymphoma |
Aug 29, 2013 | New Drug Application Filing for Ibrutinib Accepted in Two B-cell Malignancies by the U.S. FDA |
Jul 10, 2013 | New Drug Application Submitted to U.S. FDA for Ibrutinib in the Treatment of Two B-Cell Malignancies |
Jun 20, 2013 | Ibrutinib Phase 2 Study Results in Patients with Mantle Cell Lymphoma Published |
Apr 19, 2013 | Pharmacyclics Completes Enrollment of First Phase III Ibrutinib CLL Study - RESONATE™ and Announces Completion of Enrollment of Phase II Ibrutinib MCL Study - SPARK |
Dec 11, 2012 | Pharmacyclics Announces Updated Results for BTK Inhibitor Ibrutinib (PCI-32765) at American Society of Hematology (ASH) Annual Meeting |
Jun 4, 2012 | Pharmacyclics Announces Updated Results for BTK Inhibitor Ibrutinib (PCI-32765) at American Society of Clinical Oncology (ASCO) Annual Meeting |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.