The Food and Drug Administration has granted accelerated approval to Brukinsa® (zanubrutinib) for the treatment of adults with relapsed or refractory marginal zone lymphoma who have received at least 1 anti-CD20-based regimen.
The approval was based on data from the single-arm, open-label, multicenter, phase 2 MAGNOLIA trial (ClinicalTrials.gov Identifier: NCT03846427), which assessed the efficacy and safety of zanubrutinib, a Bruton tyrosine kinase (BTK) inhibitor, in 66 adults with relapsed or refractory marginal zone lymphoma. Patients received zanubrutinib 160mg orally twice daily until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR) determined by independent central review.
Results showed an ORR of 56% (n=37; 95% CI, 43-68), with 20% (n=13) of patients achieving complete response and 36% (n=24) having partial response. Based on assessment prioritizing PET-CT scan, the ORR was 67% (95% CI, 54-78), with 26% of patients achieving complete response. At the median follow-up time of 8.3 months, the median duration of response was not reached; 85% of responders remained in remission at 12 months (95% CI, 67-93). Responses were observed across all subgroups.
“The MAGNOLIA trial results provided additional evidence that the selective design of Brukinsa can be translated to improved treatment outcomes for these patients,” said Jane Huang, MD, Chief Medical Officer, Hematology at BeiGene.
Efficacy was also assessed in a global phase 1/2 trial (ClinicalTrials.gov Identifier: NCT02343120) that included 20 patients with previously treated marginal zone lymphoma. Based on assessment using CT scan, the ORR was 80% (95% CI, 56-94), with 20% of patients achieving complete response. At the median follow-up time of 31.4 months, the median duration of response was not reached; 72% of responders remained in remission at 12 months (95% CI, 40-88).
Brukinsa is also indicated for the treatment of Waldenström macroglobulinemia and mantle cell lymphoma. The product is available as 80mg capsules in 120-count bottles.
- US FDA grants Brukinsa® (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma. News release. BeiGene, Ltd. Accessed September 15, 2021. https://www.businesswire.com/news/home/20210915005310/en/U.S.-FDA-Grants-BRUKINSA%C2%AE-Zanubrutinib-Accelerated-Approval-in-Relapsed-or-Refractory-Marginal-Zone-Lymphoma.
- Brukinsa. Package insert. BeiGene, Ltd.; 2021. Accessed September 15, 2021. https://www.beigene.com/PDF/BRUKINSAUSPI.pdf?loc=US.