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

Feb 8, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in FL.

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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


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.

  1.  Health Canada approves BRUKINSA® (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma. Published Feb 7, 2024. Accessed Feb 8, 2024.

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