BeiGene, Ltd. announced that the Governments of Ontario and Quebec have publicly listed BRUKINSA® (zanubrutinib), a second generation inhibitor of Bruton's tyrosine kinase (BTK), for the treatment of adults living with chronic lymphocytic leukemia (CLL), the most common form of leukemia in adults. The Régie de l'assurance maladie du Québec listing came into effect December 13, 2023, and the Ontario Drug Benefit Program (ODB) added BRUKINSA on January 12, 2024. CLL is a type of blood cancer that is incurable and slow growing.

The condition is more common in men and occurs mainly in people over 60, with the average age of diagnosis in the early 70s.1 As there are no curative treatments for individuals living with CLL, they require continual treatment. During the course of their treatment, they might stop responding, relapse or become intolerant to their medication. BRUKINSA received its Notice of Compliance (NOC) for CLL from Health Canada on May 24th, 2023.

In addition to the new ODB and RAMQ listings, it is available through private insurance plans. BRUKINSA provides additional clinical benefit through improved progression-free survival. It is also better tolerated and has a favourable toxicity profile compared to current chemoimmunotherapy and BTK inhibitor options.

The Canadian Agency for Drugs and Technologies in Health (CADTH) recommended BRUKINSA be listed on the provinces' public health plans based on evidence from 2 ongoing phase lll, open-label randomized controlled trials (RCTs) (SEQUOIA cohort 1 and ALPINE). These trials demonstrated that treatment with zanubrutinib resulted in added clinical benefit for patients with CLL. The SEQUOIA trial cohort (N=479) demonstrated a statistically significant difference (P<0.0001) in progression-free survival (PFS) between zanubrutinib and bendamustine-rituximab treatment arms in patients with treatment-naïve CLL.

In the SEQUOIA trial, median PFS had not yet been reached in the zanubrutinib arm, whereas in the bendamustine-rituximab arm, the median PFS was 33.7 months (95% confidence interval (CI), 28.1 months to not estimable (NE]). In patients with r/r CLL, the ALPINE trial (N=652) demonstrated a statistically significant difference (P = 0.0006) in overall response rate (ORR) between the zanubrutinib and ibrutinib treatment arms (78.3% and 62.5% respectively; HR = 1.25, 95% CI, 1.10 to 1.41), demonstrating noninferiority as well as superiority of zanubrutinib to ibrutinib. The myBeiGene patient support program is designed to support patients, caregivers, and healthcare providers with access to BRUKINSA.

It goes beyond financial assistance to provide patients and caregivers with education about their disease and treatment with BRUKINSA, as well as provide practical and emotional support by connecting them to third-party resources that can address their individual needs.