Imbruvica (ibrutinib; AbbVie/Johnson & Johnson) is an oral small molecule inhibitor of Bruton’s tyrosine kinase (BTK). BTK is part of the B-cell receptor signaling pathway, which promotes cell proliferation, adhesion, and survival in many B-cell malignancies. Imbruvica has been shown to inhibit these actions and induce apoptosis in malignant B-cells in preclinical models.
Imbruvica is not expected to receive approval for the treatment of diffuse large B-cell lymphoma (DLBCL) after failing to meet the primary endpoint of improved progression-free survival (PFS) in the Phase III PHOENIX trial (ClinicalTrials.gov identifier: NCT01855750) for non-germinal center B-cell (GCB) DLBCL patients. However, AbbVie and Johnson & Johnson indicate that efficacy was seen in an unspecified subpopulation of patients, signaling that future development in this indication is possible. Potential approval, even in a small subgroup within the non-GCB subtype, would help to fill an unmet need as these patients typically have a worse prognosis and do not respond well to standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy. However, Imbruvica’s outlook will remain poor in DLBCL without clarity on the targeted patient subgroup or data to confirm efficacy.
Imbruvica (ibrutinib; AbbVie/Johnson & Johnson) is not expected to receive approval for the treatment of diffuse large B-cell lymphoma (DLBCL) after failing to meet the primary endpoint of improved progression-free survival (PFS) in the Phase III PHOENIX trial (ClinicalTrials.gov identifier: NCT01855750) for non-germinal center B-cell (GCB) DLBCL patients. However, AbbVie and Johnson & Johnson indicate that efficacy was seen in an unspecified subpopulation of patients, signaling that future development in this indication is possible. Potential approval, even in a small subgroup within the non-GCB subtype, would help to fill an unmet need as these patients typically have a worse prognosis and do not respond well to standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy. However, Imbruvica’s outlook will remain poor in DLBCL without clarity on the targeted patient subgroup or data to confirm efficacy.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Imbruvica : Chronic lymphocytic leukemia (CLL)
21 Imbruvica : NHL: Follicular lymphoma (FL)
31 Imbruvica : NHL: Diffuse large B-cell lymphoma (DLBCL)
42 Imbruvica : NHL: Mantle cell lymphoma (MCL)
LIST OF FIGURES
15 Figure 1: Datamonitor Healthcare’s drug assessment summary of Imbruvica for CLL
16 Figure 2: Datamonitor Healthcare’s drug assessment summary of Imbruvica for CLL
18 Figure 3: Imbruvica sales for CLL across the US, Japan, and five major EU markets, by country, 2017–26
24 Figure 4: Imbruvica for follicular lymphoma – SWOT analysis
25 Figure 5: Datamonitor Healthcare’s drug assessment summary of Imbruvica for follicular lymphoma
26 Figure 6: Datamonitor Healthcare’s drug assessment summary for Imbruvica in follicular lymphoma
28 Figure 7: Imbruvica sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017–26
38 Figure 8: Imbruvica for diffuse large B-cell lymphoma – SWOT analysis
39 Figure 9: Datamonitor Healthcare’s drug assessment summary for Imbruvica in diffuse large B-cell lymphoma
40 Figure 10: Datamonitor Healthcare’s drug assessment summary for Imbruvica in diffuse large B-cell lymphoma
46 Figure 11: Imbruvica for mantle cell lymphoma – SWOT analysis
47 Figure 12: Datamonitor Healthcare’s drug assessment summary of Imbruvica in mantle cell lymphoma
48 Figure 13: Datamonitor Healthcare’s drug assessment summary of Imbruvica in mantle cell lymphoma
LIST OF TABLES
6 Table 1: Imbruvica drug profile
7 Table 2: Approval history of Imbruvica for CLL in the US, Japan, and five major EU markets
9 Table 3: Trials of Imbruvica for CLL
14 Table 4: Imbruvica for CLL – SWOT analysis
21 Table 5: Imbruvica drug profile
22 Table 6: Imbruvica ongoing pivotal trial in follicular lymphoma
23 Table 7: Imbruvica clinical trial data in follicular lymphoma
29 Table 8: Imbruvica sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017–26
31 Table 9: Imbruvica drug profile
33 Table 10: Imbruvica pivotal trial data in diffuse large B-cell lymphoma
35 Table 11: Early-phase data for Imbruvica in diffuse large B-cell lymphoma
43 Table 12: Imbruvica drug profile
44 Table 13: Imbruvica pivotal trial data in mantle cell lymphoma
45 Table 14: Imbruvica late-phase trial data in mantle cell lymphoma
45 Table 15: Imbruvica ongoing late-phase clinical trials in mantle cell lymphoma
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