Health Canada approves Brukinsa for the treatment of adult patients with chronic lymphocytic leukemia
BeiGene, Ltd announced 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)
The Health Canada approval of Brukinsa for CLL is based on positive efficacy results and a favorable safety profile from two global Phase III, 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.
“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.
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