Health Canada approves zanubrutinib plus obinutuzumab for adult patients with R/R 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 1–3a 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.