Imbruvica FDA Approval History
FDA Approved: Yes (First approved November 13, 2013)
Brand name: Imbruvica
Generic name: ibrutinib
Dosage form: Capsules and Tablets
Company: AbbVie Inc.
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma; Chronic Graft Versus Host Disease
Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with:
- Mantle cell lymphoma (MCL) who have received at least one prior therapy.
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
- Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
- Waldenström’s macroglobulinemia (WM).
- Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
Development Timeline for Imbruvica
| Date | Article |
|---|
| Apr 21, 2020 | ApprovalFDA Approves Imbruvica (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL) |
| Jan 28, 2019 | ApprovalFDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia |
| Aug 27, 2018 | ApprovalFDA Approves Imbruvica (ibrutinib) Plus Rituximab for Patients with Waldenström’s Macroglobulinemia |
| Aug 2, 2017 | ApprovalFDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease |
| Jan 19, 2017 | ApprovalU.S. FDA Approves Imbruvica (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) |
| May 9, 2016 | ApprovalU.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 | ApprovalFDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia |
| Jan 29, 2015 | ApprovalFDA Expands Approved Use of Imbruvica (ibrutinib) for Waldenström’s Macroglobulinemia |
| Jul 28, 2014 | ApprovalFDA Expands Approved Use of Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia |
| Feb 12, 2014 | ApprovalFDA Approves Imbruvica (ibrutinib) to Treat Chronic Lymphocytic Leukemia |
| Nov 13, 2013 | ApprovalFDA 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 |
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