DUBLIN–(BUSINESS WIRE)–The “Imbruvica” report has been added to ResearchAndMarkets.com’s offering.
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.
Key Topics Covered:
OVERVIEW
Drug Overview
Product Profiles
Imbruvica: Chronic lymphocytic leukemia (CLL)
Imbruvica: NHL: Follicular lymphoma (FL)
Imbruvica: NHL: Diffuse large B-cell lymphoma (DLBCL)
Imbruvica: NHL: Mantle cell lymphoma (MCL)
LIST OF FIGURES
Figure 1: The authors drug assessment summary of Imbruvica for CLL
Figure 2: Imbruvica sales for CLL across the US, Japan, and five major EU markets, by country, 2017-26
Figure 3: Imbruvica for follicular lymphoma – SWOT analysis
Figure 4: The authors drug assessment summary of Imbruvica for follicular lymphoma
Figure 5: Imbruvica sales for follicular lymphoma across the US, Japan, and five major EU markets, by country, 2017-26
Figure 6: Imbruvica for diffuse large B-cell lymphoma – SWOT analysis
Figure 7: The authors drug assessment summary for Imbruvica in diffuse large B-cell lymphoma
Figure 8: Imbruvica for mantle cell lymphoma – SWOT analysis
Figure 9: The authors drug assessment summary of Imbruvica in mantle cell lymphoma
LIST OF TABLES
Table 1: Imbruvica drug profile
Table 2: Approval history of Imbruvica for CLL in the US, Japan, and five major EU markets
Table 3: Trials of Imbruvica for CLL
Table 4: Imbruvica for CLL – SWOT analysis
Table 5: Imbruvica drug profile
Table 6: Imbruvica ongoing pivotal trial in follicular lymphoma
Table 7: Imbruvica clinical trial data in follicular lymphoma
Table 8: Imbruvica sales for follicular lymphoma across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 9: Imbruvica drug profile
Table 10: Imbruvica pivotal trial data in diffuse large B-cell lymphoma
Table 11: Early-phase data for Imbruvica in diffuse large B-cell lymphoma
Table 12: Imbruvica drug profile
Table 13: Imbruvica pivotal trial data in mantle cell lymphoma
Table 14: Imbruvica late-phase trial data in mantle cell lymphoma
Table 15: Imbruvica ongoing late-phase clinical trials in mantle cell lymphoma
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Related Topics: Leukemia Drugs