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Brukinsa® Granted Approval for Treating Chronic Lymphocytic Leukemia in Canada

Tuesday, May 30, 2023

BeiGene, Ltd., a global biotechnology company, has announced that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has received approval from Health Canada for the treatment of chronic lymphocytic leukemia (CLL) in adult patients. This approval signifies a significant milestone for BRUKINSA, which now has four approved indications in Canada. The company's Chief Medical Officer, Dr. Mehrdad Mobasher, expressed their commitment to providing innovative treatment options for patients worldwide and highlighted the superior efficacy of BRUKINSA in CLL, positioning it as the preferred BTKi.

CLL is a slow-growing and incurable blood cancer that primarily affects adults, particularly those in their early 70s. Dr. Christine Chen, a Clinician Investigator at Princess Margaret Cancer Centre, emphasized the importance of effective and well-tolerated treatment options for CLL patients, given the chronic nature of the disease and the likelihood of multiple health conditions. The approval of zanubrutinib is seen as a significant advance, as it demonstrated superior efficacy compared to ibrutinib in relapsed or refractory CLL with fewer toxicities. This makes zanubrutinib a potentially safer and more effective option for CLL patients.

Health Canada's approval of BRUKINSA for CLL treatment is based on positive efficacy results and a favorable safety profile from two Phase 3 clinical trials: SEQUOIA and ALPINE. The SEQUOIA trial compared zanubrutinib to bendamustine plus rituximab (BR) in previously untreated CLL patients, while the ALPINE trial compared zanubrutinib to ibrutinib in relapsed or refractory CLL patients. The ALPINE trial, in particular, is considered the largest head-to-head study of BTK inhibitors in relapsed or refractory CLL. The final data from the ALPINE trial were presented at the American Society of Hematology Annual Meeting and published in The New England Journal of Medicine.

CLL Canada, an organization supporting CLL patients, commended the approval of zanubrutinib, as it provides an additional treatment option for patients. They emphasized the importance of patient education and connection to the CLL patient community to facilitate informed discussions with healthcare professionals about the most suitable treatment options.

BRUKINSA (zanubrutinib) is a small-molecule inhibitor of Bruton's tyrosine kinase that was discovered by BeiGene scientists. It is currently being evaluated in various clinical trials globally as a monotherapy and in combination with other therapies for the treatment of B-cell malignancies. BRUKINSA's unique pharmacokinetics optimize its bioavailability, half-life, and selectivity, resulting in targeted and sustained inhibition of the BTK protein. The drug has demonstrated efficacy in inhibiting the proliferation of malignant B cells in relevant disease tissues. With approvals in over 65 markets worldwide, including the United States, China, the European Union, and Australia, BRUKINSA has established a strong global presence.



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