16 June 2026
16 June 2026
The approval is based on global Phase III QUANTI studies evaluating Ambelvist's efficacy and safety in adults and children.
The authorisation extends access to a treatment option previously confined to injection-based administration.
The study included 639 patients, 79.8% of whom had previously received covalent BTK inhibitors.
The approvals are based on data from the pivotal Phase III LITESPARK-022 trial, which enrolled 1,841 patients.
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