Benzinga | Sep 15, 2021 07:08AM EDT

BeiGene Announces The US FDA Has Granted BRUKINSA Accelerated Approval In Relapsed Or Refractory Marginal Zone Lymphoma

This marks the third FDA approval for BRUKINSA and first approval in marginal zone lymphoma

Twenty percent of patients achieved complete remission with single-agent BRUKINSA

BRUKINSA was generally well-tolerated, consistent with its known safety profile

BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160))))), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA(r) (zanubrutinib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

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(Photo: Business Wire)

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.

"We are excited about the FDA's approval for BRUKINSA in patients with previously treated marginal zone lymphoma, a significant milestone that was made possible by the diligent BeiGene team, the dedicated investigators, and the participating patients and their families. 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, M.D., Chief Medical Officer, Hematology at BeiGene. "The ongoing evaluation of BRUKINSA in its broad global clinical program will enable us to further understand this potentially best-in-class BTK inhibitor and its impact on patients. Since the initial FDA approval in November 2019, BRUKINSA has been granted 12 approvals in four indications globally. We will continue to execute on our mission to improve access to innovative and quality treatments for cancer patients worldwide."