Zanubrutinib (BeiGene) is an oral small molecule inhibitor of Bruton's tyrosine kinase (BTK), developed to be more selective with less off-target effects than Imbruvica (ibrutinib; AbbVie/Johnson & Johnson). BTK is part of the B-cell receptor signaling pathway, which promotes cell proliferation, adhesion, and survival in many B-cell malignancies.
Zanubrutinib is currently under development for both treatment-nave and relapsed/refractory chronic lymphocytic leukemia (CLL). While early-phase trials of zanubrutinib have demonstrated promising safety and efficacy, the drug will face significant competition in both the first-line and second-line settings from more well-established therapies in this increasingly crowded indication.
In particular, Imbruvica will serve as a significant barrier to market entry. Not only does Imbruvica share the same mechanism of action as zanubrutinib, but the drug is already approved and widely used in a variety of CLL treatment settings. Nonetheless, BeiGene has initiated a Phase III head-to-head trial testing zanubrutinib against Imbruvica. If zanubrutinib can demonstrate statistically significant improvements in efficacy over Imbruvica, the drug could quickly grow to become an important part of the CLL treatment algorithm.
Key Topics Covered:
zanubrutinib: Chronic lymphocytic leukemia (CLL)
zanubrutinib: NHL: Follicular lymphoma (FL)
LIST OF FIGURES
Figure 1: The authors drug assessment summary of zanubrutinib for CLL
Figure 2: Zanubrutinib sales for CLL across the US and five major EU markets, by country, 2017-26
Figure 3: Zanubrutinib for follicular lymphoma - SWOT analysis
Figure 4: The authors drug assessment summary of zanubrutinib for follicular lymphoma
Figure 5: Zanubrutinib sales for follicular lymphoma across the US and five major EU markets, by country, 2017-26
LIST OF TABLES
Table 1: Zanubrutinib drug profile
Table 2: Trials for zanubrutinib in CLL
Table 3: Zanubrutinib for CLL - SWOT analysis
Table 4: Zanubrutinib drug profile
Table 5: Zanubrutinib ongoing late-phase clinical trial in follicular lymphoma
Table 6: Zanubrutinib sales for follicular lymphoma across the US and five major EU markets, by country ($m), 2017-26
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