BeiGene, Ltd. announced it received Health Canada authorization for the use of BRUKINSA® (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL) who have received at least two prior systemic therapies. This marks the fifth hematology indication for BRUKINSA in Canada following approvals for the treatment of adult patients with Waldenström's macroglobulinemia (WM); adult patients who have received at least one prior therapy for the treatment of mantle cell lymphoma (MCL); adult patients with relapsed or refractory marginal zone lymphoma (MZL) and adult patients with chronic lymphocytic leukemia (CLL). patients can now benefit from BRUKINSA and are proud to highlight BeiGene's unwavering commitment to improving cancer patient outcomes and having a positive impact on their lives." The Canadian approval is based on positive results from ROSEWOOD (NCT03332017), a pivotal global, randomized, open-label Phase 2 study comparing the highly selective Bruton's tyrosine kinase (BTK) inhibitor BRUKINSA combined with obinutuzumab vs.

obinutuzumab alone. At 20.2 months the ROSEWOOD trial met its primary endpoint, demonstrating a statistically significantly higher Objective Response Rate (ORR), as assessed by the Independent Review Committee (IRC). BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines and showed consistent benefit over obinutuzumab in pre-specified subgroups.

Additionally, the median progression-free survival (PFS) for patients treated with BRUKINSA plus obinutuzumab was 28.0 months, compared to 10.4 months for patients treated with only obinutuzumab (HR: 0.50 [95% CI: 0.33, 0.75]; P = 0.0007). FL is the second most common type of non-Hodgkin lymphoma (NHL), accounting for 22% of all NHL cases. While patients with FL may experience very few symptoms or none at all, the most common symptom is a painless swelling in the neck, armpit or groin regions caused by enlarged lymph nodes.

Patients may also experience fatigue, loss of appetite, or itchy skin. FL is a slow-growing cancer but can become more aggressive over time. While FL remains incurable, individuals with this condition can live a long time.

FL usually occurs in people 50 years of age or older, and the average age at diagnosis is 59. It is slightly more common in women than in men.