Health Canada approved BRUKINSA based on positive efficacy results and a favourable safety profile from two global late-stage randomised, open-label, multicentre clinical trials
BeiGene gets approval for BRUKINSA in Canada. (Credit: Business Wire)
Biotechnology company BeiGene has received approval from Health Canada for BRUKINSA (zanubrutinib) to treat adult patients with chronic lymphocytic leukaemia (CLL).
BRUKINSA is a small-molecule Bruton’s tyrosine kinase inhibitor (BTKi). It provides targeted and sustained inhibition of the BTK protein by improving bioavailability, half-life, and selectivity.
BeiGene Hematology chief medical officer Mehrdad Mobasher said: “BRUKINSA now has four approved indications in Canada, demonstrating our commitment to bring this innovative BTKi treatment option to more patients across the world.
“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.”
Health Canada approved BRUKINSA based on positive efficacy results and a favourable safety profile from two global late-stage randomised, open-label, multicentre clinical trials.
SEQUOIA trial compared the BTKi therapy with bendamustine plus rituximab (BR) in patients with previously untreated CLL. The ALPINE study compared BRUKINSA against ibrutinib in individuals with relapsed or refractory (R/R) CLL.
The final ALPINE trial is said to be the largest head-to-head study of BTK inhibitors in R/R CLL. Its results were published in The New England Journal of Medicine.
Additionally, the findings from the SEQUOIA trial results were published in The Lancet Oncology in August last year.
Currently, BTKi therapy is being assessed globally in a broad clinical program as a monotherapy and in combination with other therapies for the treatment of different B-cell malignancies.
BeiGene said that the BTK inhibitor is supported by a broad clinical programme that has more than 4,900 subjects in 35 trials across 29 markets.
The therapy is already approved in more than 65 markets globally, including the US.
Recently, BRUKINSA secured approval from the China National Medical Products Administration (NMPA).
The approval included two supplemental new drug applications to treat chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM).