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PMID
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Title Imbruvica (ibrutinib) FDA Drug Label
Journal
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210563
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Ibrutinib Imbruvica PCI-32765 BTK inhibitor 22 EGFR Inhibitor (Pan) 46 HER2 Inhibitor 23 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
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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 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 + 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
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 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 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