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Title | Imbruvica (ibrutinib) FDA Drug Label |
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210563 |
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Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Ibrutinib | Imbruvica | PCI-32765 | BTK inhibitor 24 EGFR Inhibitor (Pan) 47 HER2 Inhibitor 26 | Imbruvica (ibrutinib) is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), which promotes apoptosis and inhibits B-cell mediated signaling pathways, and has additional activity against ERBB2 (HER2) and EGFR (PMID: 20615965, PMID: 21422473, PMID: 27678331). Imbruvica (Ibrutinib) is FDA approved for use in patients with mantle cell lymphoma, CLL/SLL and CLL/SLL with del 17p, Waldenstroem’s macroglobulinemia, marginal zone lymphoma, and in combination with Rituxan (rituximab) for untreated CLL/SLL (FDA.gov). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Unknown unknown | marginal zone B-cell lymphoma | not applicable | Ibrutinib | FDA approved | Actionable | In a Phase II trial that supported FDA approval, Imbruvica (ibrutinib) treatment resulted in an objective response rate of 48% (29/60) in patients with previously treated marginal zone lymphoma, with a median progression-free survival of 14.2 months (PMID: 28167659; NCT01980628). | 28167659 detail... |
Unknown unknown | CLL/SLL | not applicable | Ibrutinib | FDA approved | Actionable | In a Phase III trial (RESONATE) that supported FDA approval, treatment with Imbruvica (ibrutinib) in chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) patients with del 17p resulted in improved progression-free survival compared to Arzerra (ofatumumab) (40.6 vs. 8.1 months), and improved overall response rate (47.6%, 30/63 vs 4.7%, 3/64) (PMID: 31512258; NCT01578707). | 31512258 detail... |
Unknown unknown | CLL/SLL | not applicable | Ibrutinib | FDA approved | Actionable | In a Phase III trial (RESONATE) that supported FDA approval, treatment with Imbruvica (ibrutinib) in chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) patients resulted in improved progression-free survival compared to treatment with Arzerra (ofatumumab) (median duration not reached vs. 8.1 months), and an overall response rate of 43% (83/195) versus 4% (8/196) with Arzerra (ofatumumab) (PMID: 24881631; NCT01578707). | detail... 24881631 |
Unknown unknown | CLL/SLL | not applicable | Ibrutinib | FDA approved | Actionable | In a Phase III trial (RESONATE-2) that supported FDA approval, Imbruvica (ibrutinib) treatment resulted in a greater median progression-free survival (not reached vs 18.9 months, HR=0.16, p<0.001) and response rate (86% vs 35%, p<0.001) when compared to chlorambucil treatment in patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) aged 65 or older (PMID: 26639149; NCT01722487). | detail... 26639149 |
Unknown unknown | mantle cell lymphoma | not applicable | Ibrutinib | FDA approved | Actionable | In a Phase II trial (Study 1104) that supported FDA approval, Imbruvica (ibrutinib) treatment resulted in a response rate of 68% (75/111, complete response 21%, partial response 47%), with an estimated median progression-free survival of 13.9 months in patients with relapsed or refractory mantle-cell lymphoma (PMID: 23782157, NCT01236391). | 23782157 detail... |
Unknown unknown | Waldenstroem's macroglobulinemia | not applicable | Ibrutinib | FDA approved | Actionable | In a Phase II trial that supported FDA approval, Ibruvica (ibrutinib) treatment resulted in an overall response rate of 90.5% and a major response rate of 73.0% in patients with previously treated Waldenstroem's macroglobulinemia (PMID: 25853747; NCT01614821). | 25853747 detail... |
Unknown unknown | CLL/SLL | not applicable | Ibrutinib + Rituximab | FDA approved | Actionable | In a Phase III trial that supported FDA approval, combination of Imbruvica (ibrutinib) and Rituxan (rituximab) resulted in superior progression-free survival at 3 years (89.4% vs 72.9%, HR=0.35, p<0.001) and overall survival at 3 years (98.8% vs 91.5%, HR=0.17, p<0.001) compared to chemoimmunotherapy in patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (PMID: 31365801; NCT02048813). | detail... 31365801 |