Imbruvica Approval History
FDA Approved: Yes (First approved November 13, 2013)
Brand name: Imbruvica
Generic name: ibrutinib
Dosage form: Capsules and Tablets
Company: Janssen Biotech, Inc.
Treatment for: Lymphoma, Chronic Lymphocytic Leukemia, Graft-versus-host disease
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 |
|---|
| Jan 28, 2019 |  FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia |
| Aug 27, 2018 | FDA Approves Imbruvica (ibrutinib) Plus Rituximab for Patients with Waldenström’s Macroglobulinemia |
| 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 |
Further information
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