BeiGene, Ltd. announced that Swissmedic has accepted the marketing authorization applicationfor BRUKINSA, a treatment option for adult patients with Waldenströms macroglobulinaemia. Swissmedic has started the formal review of the MAA. BRUKINSA has already been granted orphan drug status by Swissmedic. Swissmedic, the Swiss Agency for Therapeutic Products, reviews new products for market authorization. Within this process, Swissmedic evaluates a products quality, safety, and effectiveness through clinical trial data. The MAA is supported by data from the randomized Phase 3 ASPEN clinical trial (NCT03734016), evaluating zanubrutinib compared to ibrutinib in adult patients with WM. The approval by Swissmedic would grant marketing authorization for BRUKINSA in WM within Switzerland.