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indications for Imbruvica for the treatment of mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) were withdrawn in May 2023.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studies were considered insufficient to support conversion to full approval, and the indications were voluntarily withdrawn.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
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