Imbruvica
Publisher: Datamonitor Healthcare
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Drug Overview
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.
Analyst Outlook
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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