BeiGene Receives EU Approval for Brukinsa® (Zanubrutinib) in Relapsed/Refractory Follicular Lymphoma: Expanding Treatment Options in the EU

BeiGene recently announced that the European Commission (EC) has granted marketing authorization for Brukinsa® (zanubrutinib) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. This approval marks the fourth indication for Brukinsa® in the European Union (EU), solidifying its position as the broadest applicable Bruton's tyrosine kinase (BTK) inhibitor in the EU region.

Approval Based on ROSEWOOD Study:
The approval is based on positive results from the ROSEWOOD study (NCT03332017), a global Phase 2 trial that compared zanubrutinib in combination with rituximab against rituximab monotherapy in 217 patients with R/R FL who had received at least two prior systemic therapies. In the study, the overall response rate (ORR) for the zanubrutinib plus rituximab treatment group was 69.0%, compared to 45.8% for the rituximab monotherapy group (P=0.0012), with a median follow-up of approximately 20 months. The zanubrutinib plus rituximab treatment group demonstrated sustained responses, with 69.3% of patients achieving a duration of response (DoR) of at least 18 months.

Furthermore, the median progression-free survival (PFS) for the zanubrutinib plus rituximab treatment group was 28.0 months, compared to 10.4 months for the rituximab monotherapy group (HR: 0.50 [95% CI: 0.33, 0.75]; P=0.0007).

Good Tolerability and Safety Profile:
Overall, the combination of zanubrutinib and rituximab demonstrated good tolerability, and the safety profile was consistent with previous observations of these two drugs in other studies.

Additional Indications and Regulatory Submissions:
In addition to R/R FL, Brukinsa® is currently approved in the EU as a monotherapy for adult patients with chronic lymphocytic leukemia (CLL), as a monotherapy for adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 therapy, and for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for WM patients who are not eligible for chemoimmunotherapy.

BeiGene has submitted regulatory filings for the use of Brukinsa® in R/R FL to the U.S. and Chinese regulatory authorities, which are currently under review. Additionally, the regulatory submissions for the use of Brukinsa® in R/R FL as part of the Access Consortium's new active substance work-sharing initiative are being reviewed by regulatory authorities in Canada, Switzerland, and the UK.

Global Approvals and Clinical Development:
Brukinsa® has been approved for multiple indications in over 65 markets worldwide, including the United States, China, the EU, the UK, Canada, Australia, South Korea, and Switzerland. Furthermore, Brukinsa® is under clinical development in other countries and regions. The global clinical trial program for Brukinsa® has enrolled over 5,000 patients across 29 countries and regions.

The EU approval of Brukinsa® (zanubrutinib) for the treatment of R/R follicular lymphoma expands treatment options for adult patients in the EU region. The approval was based on positive results from the ROSEWOOD study, demonstrating significant improvements in overall response rates and progression-free survival compared to rituximab monotherapy. Brukinsa® continues to show a favorable tolerability and safety profile.

With its broad indications and ongoing clinical development, Brukinsa® represents a promising treatment option for various B-cell malignancies. Regulatory submissions for additional indications and regions are underway, further supporting the potential global impact of this novel BTK inhibitor.