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BeiGene Announces Health Canada Approval for BRUKINSA® (zanubrutinib) in Relapsed or Refractory Marginal Zone Lymphoma

Follows U.S. approval for relapsed or refractory marginal zone lymphoma in 2021

Third approved indication for BRUKINSA in Canada, following mantle cell lymphoma (MCL) and Waldenström’s macroglobulinemia (WM)

Excerpt from the Press Release:

MISSISSAUGA, Ontario & CAMBRIDGE, Mass. & BEIJING & BASEL, Switzerland–(BUSINESS WIRE)–BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, today announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

“We are pleased that BRUKINSA is now approved in its third indication in Canada, R/R MZL, and this terrific milestone was made possible by the participating patients and investigators. This approval further supports our belief that BRUKINSA is a potentially best-in-class BTK inhibitor, with the MAGNOLIA trial results in R/R MZL providing additional evidence that the selective design of BRUKINSA can be translated into improved treatment outcomes,” said Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. “We will continue to work with physicians and their patients as part of our broad global clinical program for BRUKINSA, which includes 35 trials and more than 3,900 subjects across 28 markets.”

“BRUKINSA is a highly selective next-generation BTK inhibitor designed to improve tolerability by minimizing off-target binding. In clinical trials, BRUKINSA achieved a high overall response rate among relapsed/refractory MZL patients and was generally well-tolerated. With this approval, Canadian patients with R/R MZL will have the option to receive BRUKINSA monotherapy as a treatment and a new hope for improved treatment outcomes,” said Dr. Anthea Peters, a hematologist at the Cross Cancer Institute in Edmonton, Alberta.

“The approval of this medicine for the treatment of R/R MZL represents a new treatment option and is welcome news to Canadians living with this rare type of lymphoma,” commented Antonella Rizza, Chief Executive Officer of Lymphoma Canada.

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