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Brukinsa based on Zanubrutinib for the treatment of relapsed or refractory follicular lymphoma. European Commission approval

The European Commission ( EC ) has granted marketing authorization for Brukinsa ( Zanubrutinib) in combination with Obinutuzumab for the treatment of adult patients with relapsed or refractory ( R/R ) follicular lymphoma ( FL ) who have received at least two prior lines of systemic therapy.
This marks the fourth indication in the European Union ( EU ) for Brukinsa, which is now approved to treat more patient populations in the EU than any other Bruton’s tyrosine kinase ( BTK ) inhibitor.

The EC approval is based on positive results from ROSEWOOD, a global, randomized, open-label phase 2 study of Zanubrutinib plus Obinutuzumab compared with Obinutuzumab alone in 217 patients with relapsed or refractory follicular lymphoma who received at least two prior lines of systemic therapy.
In the study, the overall response rate was 69.0% in the Zanubrutinib plus Obinutuzumab arm versus 45.8% in the Obinutuzumab arm ( P = 0.0012 ), with a median follow-up of approximately 20 months. Responses were durable with 18-month landmark duration of response ( DoR ) of 69.3% in the Zanubrutinib combination arm.
The median progression-free survival ( PFS ) for patients treated with Zanubrutinib plus Obinutuzumab was 28.0 months, compared to 10.4 months for patients treated with only Obinutuzumab ( hazard ratio, HR: 0.50 [ 95% CI: 0.33, 0.75 ]; P = 0.0007 ).

Zanubrutinib plus Obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines.

In addition to relapsed or refractory follicular lymphoma, Brukinsa is approved in the European Union as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia, for adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy, and for adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy.

Follicular lymphoma is the second most common type of non-Hodgkin lymphoma ( NHL ), accounting for 22% of all NHL cases.
Across Europe, over 122,000 people each year are diagnosed with non-Hodgkin lymphoma.
Follicular lymphoma is a slow-growing cancer but can become more aggressive over time.
While follicular lymphoma remains incurable, people with the condition can live a long time. The five-year survival rate is about 90%, and approximately half of people diagnosed with follicular lymphoma can live with the disease for nearly 20 years. ( Xagena )

Source: BeiGene, 2023