BeiGene, Ltd. announced that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström’s macroglobulinaemia (WM). 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 product’s quality, safety, and effectiveness through clinical trial data.

Gerwin Winter, Senior Vice President, Head of Commercial, Europe, at BeiGene said: “The acceptance of the marketing authorization application of BRUKINSA by Swissmedic is a crucial step in the development of BRUKINSA for Swiss patients with WM. We are looking forward to continuing our work with the health authorities to bring BRUKINSA to patients living with this rare, incurable blood cancer.”

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.