On May 30, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that BRUKINSA (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL) (Press release, BeiGene, MAY 30, 2023, View Source [SID1234632202]).
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"BRUKINSA now has four approved indications in Canada, demonstrating our commitment to bring this innovative BTKi treatment option to more patients across the world," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "Our bold development program for BRUKINSA in CLL provided evidence for superior efficacy in the first-line and relapsed/refractory treatment settings, positioning BRUKINSA to become the BTKi of choice."
Typically diagnosed among individuals in their early 70s, CLL is a slow-growing, incurable blood cancer and is the most common leukemia in adults.1
"Because CLL is a chronic disease with many patients often living with multiple health conditions, access to effective treatment options with safe and favorable tolerability profiles is critical," says Dr. Christine Chen, MMEd, MD, FRCPC, Clinician Investigator, Princess Margaret Cancer Centre. "That is why the approval of zanubrutinib is seen as a clinical home run – not only did it demonstrate a significant clinical benefit in the first line CLL setting but it delivered superior efficacy versus ibrutinib in patients with relapsed or refractory disease and did so with less toxicity. And because most CLL patients are ultimately treated on and off for years, zanubrutinib may represent a safer and more effective option for patients with CLL."
The Health Canada approval of BRUKINSA for CLL is based on positive efficacy results and a favorable safety profile from two global Phase 3, randomized, open-label, multicenter clinical trials: SEQUOIA (NCT03336333), comparing zanubrutinib against bendamustine plus rituximab (BR) in patients with previously untreated CLL, and ALPINE (NCT03734016), comparing zanubrutinib against ibrutinib in patients with relapsed or refractory (R/R) CLL.2
Considered the largest head-to-head study of BTK inhibitors in R/R CLL, the final ALPINE trial data were presented in a late-breaking session at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022 and simultaneously reported in The New England Journal of Medicine.3,4 SEQUOIA trial results were published in The Lancet Oncology in August 2022.5
"CLL Canada applauds continued innovation when it comes to addressing the needs of Canadians who live with CLL. The approval of zanubrutinib represents a significant advance for patients who can benefit from an additional treatment option," says Raymond Vles, Board Chair, CLL Canada. "More importantly, becoming informed and connecting with the CLL patient community will enable people with CLL to discuss with their doctor the treatment and dosing options that will work best for them and their lifestyle."
About CLL2
CLL is a type of blood cancer. Over 2,200 people in Canada are diagnosed with CLL each year. CLL is more common in men and occurs mainly in people over 60, with the average age of diagnosis in the early 70s.
About BRUKINSA (zanubrutinib)
BRUKINSA is a small-molecule inhibitor of Bruton’s tyrosine kinase discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.
BRUKINSA is supported by a broad clinical program which includes more than 4,900 subjects in 35 trials across 29 markets. To date, BRUKINSA is approved in more than 65 markets around the world, including the United States, China, the European Union, Great Britain, Canada, Australia, South Korea, and Switzerland.