BeiGene’s Brukinsa (zanubrutinib) Receives Health Canada’s Approval for Waldenström’s Macroglobulinemia

Shots:

• The approval is based on a P-III APSEN study involve assessing Brukinsa vs ibrutinib in 201 patients with r/r or TN WM who harbor an MYD88 mutation (MYD88MUT). The recommended dose of the therapy is 320mg and is expected to be available in Canada imminently
• The P-III APSEN study demonstrated clinical benefit with advantages in safety, the combined CR + VGPR rate in the overall ITT population was 28.4% vs 19.2% as assessed by IRC per adaptation of the response criteria updated at the 6th IWWM
• Brukinsa (BGB-3111) is a BTK inhibitor, currently being evaluated in multiple clinical studies globally as a monothx. or in combination with other therapies targeting B cell malignancies

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