Shots:

• The MAA was based on the P-III (ASPEN) trial to evaluate Brukinsa vs ibrutinib in 101 patients with WM who harbor an MYD88 mutation & received one prior line of therapy or who are not suited for standard chemo-immunotherapy in treatment-naïve patients
• The results showed a higher VGPR rate & a favorable safety profile, CR + VGPR rate in the overall ITT population (29% vs 19%) as assessed by IRC per adaptation of the response criteria updated at 6th IWWM
• Additionally, 4% of patients lead to discontinuation due to AEs. Brukinsa is a BTK inhibitor & is currently being evaluated globally in a broad clinical program as a monothx. & in combination with other therapies for B-cell malignancies

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