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Health Canada approves zanubrutinib plus obinutuzumab for adult patients with R/R FL

By Sabina Ray

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Feb 8, 2024

Learning objective: After reading this article, learners will be able to cite a new clinical development in FL.


On February 7, 2024, Health Canada approved zanubrutinib, a Bruton’s tyrosine kinase inhibitor, in combination with obinutuzumab, an antibody therapy, for the treatment of adult patients with relapsed/refractory Grade 13a follicular lymphoma after 2 systemic therapies. This approval is based on positive results from the pivotal phase II ROSEWOOD trial.

The ROSEWOOD trial1

The ROSEWOOD trial (NCT03332017) is a global, open-label study investigating zanubrutinib plus obinutuzumab vs obinutuzumab alone. The trial met its primary endpoint with a significantly higher objective response rate in the zanubrutinib plus obinutuzumab arm. The Lymphoma Hub previously reported the trial design and promising results (Figure 1).

Figure 1. Median progression-free survival in zanubrutinib plus obinutuzumab vs obinutuzumab arm.* 

*Data from Newswire.1

Conclusion1

The approval of zanubrutinib plus obinutuzumab in Canada provides patients with the first and only Bruton’s tyrosine kinase inhibitor for the treatment of follicular lymphoma.

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