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Imbruvica FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 13, 2023.

FDA Approved: Yes (First approved November 13, 2013)
Brand name: Imbruvica
Generic name: ibrutinib
Dosage form: Capsules, Tablets and Oral Suspension
Company: AbbVie Inc.
Treatment for: Chronic Lymphocytic Leukemia, Waldenström Macroglobulinemia, Graft-versus-host disease, Lymphoma

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD).

  • Imbruvica is indicated for the treatment of:
    • Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) in adult patients.
    • Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) with 17p Deletion in adult patients.
    • Waldenström’s Macroglobulinemia (WM) in adult patients.
    • Chronic Graft Versus Host Disease (cGVHD) in adult and pediatric patients age 1 year and older after failure of one or more lines of systemic therapy.
  • Imbruvica is administered orally once daily.
  • Imbruvica is associated with the following warnings and precautions: hemorrhage; infections; cardiac arrhythmias, cardiac failure, and sudden death; hypertension; cytopenias; second primary malignancies; tumor lysis syndrome (TLS); and embryo-fetal toxicity.
  • Common adverse reactions in patients with B-cell malignancies (CLL/SLL and WM) include thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, and nausea.
    Common adverse reactions in adult or pediatric patients with cGVHD are fatigue, anemia, bruising, diarrhea, thrombocytopenia, musculoskeletal pain, pyrexia, muscle spasms, stomatitis, hemorrhage, nausea, abdominal pain, pneumonia, and headache.
  • The accelerated approval indications for Imbruvica for the treatment of mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) were withdrawn in May 2023. The FDA had previously granted accelerated approval for Imbruvica in MCL and MZL based on overall response rates in two Phase 2 clinical studies, and continued approval was contingent upon demonstration of clinical benefit in confirmatory Phase 3 studies. The primary outcomes from the confirmatory Phase 3 studies studies were considered insufficient to support conversion to full approval, and the indications were voluntarily withdrawn.

Development timeline for Imbruvica

Apr  6, 2023Update on Imbruvica (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications
Aug 24, 2022Approval U.S. FDA Approves Imbruvica (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease
Apr 21, 2020Approval FDA Approves Imbruvica (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
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

Further information

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