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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

DateArticle
Apr 21, 2020ApprovalFDA Approves Imbruvica (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
Jan 28, 2019ApprovalFDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Aug 27, 2018ApprovalFDA Approves Imbruvica (ibrutinib) Plus Rituximab for Patients with Waldenström’s Macroglobulinemia
Aug  2, 2017ApprovalFDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease
Jan 19, 2017ApprovalU.S. FDA Approves Imbruvica (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL)
May  9, 2016ApprovalU.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, 2016ApprovalFDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia
Jan 29, 2015ApprovalFDA Expands Approved Use of Imbruvica (ibrutinib) for Waldenström’s Macroglobulinemia
Jul 28, 2014ApprovalFDA Expands Approved Use of Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia
Feb 12, 2014ApprovalFDA Approves Imbruvica (ibrutinib) to Treat Chronic Lymphocytic Leukemia
Nov 13, 2013ApprovalFDA 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

Further information

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