BeiGene: Swissmedic Begins Formal Review Of MAA For BRUKINSA - Quick Facts

Biotechnology company BeiGene, Ltd. (BGNE) said Swissmedic, the Swiss Agency for Therapeutic Products, has accepted the marketing authorization application for BRUKINSA (Zanubrutinib) in Waldenström's Macroglobulinaemia. The MAA is supported by data from the randomized phase 3 ASPEN clinical trial, evaluating zanubrutinib compared to ibrutinib in adult patients with Waldenström's macroglobulinaemia.

BRUKINSA is a small molecule inhibitor of Bruton's tyrosine kinase which is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

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