BeiGene, Ltd. announces U.S. Food and Drug Administration Grants Brukinsa Approval in Relapsed or Refractory Marginal Zone Lymphoma
September 15, 2021 at 12:00 pm
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BeiGene, Ltd. announced that BRUKINSA has received accelerated approval from the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen. This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA approval of BRUKINSA is based on efficacy results from two single-arm clinical trials, with ORR as assessed by independent review committee per 2014 Lugano Classification as the primary endpoint. In the multicenter, pivotal Phase 2 MAGNOLIA trial in patients with R/R MZL who received at least one anti-CD20-based regimen, a total of 66 patients were evaluated, including 26 with extranodal subtype, 26 with nodal subtype, 12 with splenic subtype, and four with unknown subtype. Based on assessment using CT scan, the ORR was 56% with a complete response rate of 20%; based on assessment prioritizing PET-CT scan, the ORR was 67% with a CR rate of 26%. The median duration of response was not reached at the median follow-up time of 8.3 months, with 85% of responders still in remission at 12 months. Responses were observed in all MZL subtypes. In the global Phase 1/2 trial of BGB-3111-AU-003, a total of 20 patients were evaluated, including nine with extranodal subtype, five with nodal subtype, and six with splenic subtype. Based on assessment using CT scan, the ORR was 80% with a CR rate of 20%. The median DoR was not reached at the median follow-up time of 31.4 months, with 72% of responders still in remission at 12 months. The most common adverse reactions, including laboratory abnormalities, in the pooled safety population of 847 patients were decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, decreased lymphocyte count, rash, and musculoskeletal pain. The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.
BeiGene, Ltd. is a global biotechnology company engaged in discovering and developing oncology treatments for cancer patients worldwide. The Company has discovered and developed three approved medicines, including BRUKINSA, a small molecule inhibitor of Brutonâs Tyrosine Kinase for the treatment of various blood cancers; TEVIMBRA (tislelizumab), an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers; and pamiparib, a selective small molecule inhibitor of poly ADP-ribose polymerase 1 (PARP1) and PARP2. The Company has obtained approvals to market BRUKINSA in the United States, the People's Republic of China (China or the PRC), the European Union, the United Kingdom, Canada, Australia, and additional international markets; tislelizumab in the European Union and China; and pamiparib in China. It also focuses on commercializing cancer medicines, such as XGEVA, BLINCYTO, KYPROLIS, and others in China under an exclusive license from Amgen Inc.