FDA approves Brukinsa for advanced marginal zone lymphoma
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The FDA granted accelerated approval to zanubrutinib for treatment of patients with relapsed or refractory marginal zone lymphoma who received at least one anti-CD-20-based regimen.
Zanubrutinib (Brukinsa, BeiGene) is a small-molecule inhibitor of Bruton tyrosine kinase (BTK) in development as monotherapy or part of combination therapy for treatment of various B-cell malignancies. It already had been approved in the United States for treatment of adults with mantle cell lymphoma who received at least one prior therapy, and for adults with Waldenström macroglobulinemia.
The FDA based the newest indication on results of two single-arm clinical trials, both of which used overall response rate assessed by independent review committee as the primary endpoint.
The multicenter phase 2 MAGNOLIA trial included 66 patients with relapsed or refractory marginal zone lymphoma who received at least one anti-CD20-based regimen. Median follow-up was 8.3 months.
Researchers reported an ORR of 56% (95% CI, 43-68) and a complete response rate of 20%. Median duration of response had not been reached, but 85% (95% CI, 67-93) of patients who achieved response remained in remission for at least 12 months.
Investigators observed responses in all subtypes, including nodal, extranodal and splenic disease.
The phase 1/phase 2 BGB-3111-AU-003 trial included 20 patients. Median follow-up was 31.4 months.
CT scan assessment showed an ORR of 80% (95% CI, 56-94), with a 20% complete response rate. Median duration of response had not been reached, but 72% (95% CI, 40-88) of patients who achieved response remained in remission at 12 months.
The most common adverse events reported in a pooled safety population (n = 847) included decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, decreased lymphocyte count, rash and musculoskeletal pain.
“BTK plays a critical role in B-cell receptor signaling, a driver in the development of marginal zone lymphoma,” Stephen Opat, FRACP, FRCPA, MBBS, director of clinical hematology at Monash Health, head of the department of hematology at Monash University and principal investigator of the MAGNOLIA trial, said in a BeiGene-issued press release. “We are optimistic that Brukinsa will bring clinically meaningful benefit to patients with relapsed or refractory marginal zone lymphoma.”
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