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Molecular Profile Unknown unknown
Therapy Ibrutinib
Indication/Tumor Type CLL/SLL
Response Type not applicable

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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 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...
PubMed Id Reference Title Details
(26639149) Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. Full reference...
(24881631) Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. Full reference...
Imbruvica (ibrutinib) FDA Drug Label Full reference...
Imbruvica (ibrutinib) FDA Drug Label Full reference...
Imbruvica (ibrutinib) FDA Drug Label Full reference...
(31512258) Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Full reference...