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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

Jan 28, 2019Approval FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Aug 27, 2018Approval FDA Approves Imbruvica (ibrutinib) Plus Rituximab for Patients with Waldenström’s Macroglobulinemia
Aug  2, 2017Approval FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease
Jan 19, 2017Approval U.S. FDA Approves Imbruvica (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL)
May  9, 2016Approval 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, 2016Approval FDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia
Jan 29, 2015Approval FDA Expands Approved Use of Imbruvica (ibrutinib) for Waldenström’s Macroglobulinemia
Jul 28, 2014Approval FDA Expands Approved Use of Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia
Feb 12, 2014Approval FDA Approves Imbruvica (ibrutinib) to Treat Chronic Lymphocytic Leukemia
Nov 13, 2013Approval FDA Approves Imbruvica (ibrutinib) 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
Jun 20, 2013Ibrutinib Phase 2 Study Results in Patients with Mantle Cell Lymphoma Published
Apr 19, 2013Pharmacyclics Completes Enrollment of First Phase III Ibrutinib CLL Study - RESONATE™ and Announces Completion of Enrollment of Phase II Ibrutinib MCL Study - SPARK
Dec 11, 2012Pharmacyclics Announces Updated Results for BTK Inhibitor Ibrutinib (PCI-32765) at American Society of Hematology (ASH) Annual Meeting
Jun  4, 2012Pharmacyclics Announces Updated Results for BTK Inhibitor Ibrutinib (PCI-32765) at American Society of Clinical Oncology (ASCO) Annual Meeting

Further information

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