Benzinga | May 19, 2021 07:02AM EDT

BeiGene Announces FDA Acceptance And Priority Review Of Supplemental New Drug Application For BRUKINSA In Marginal Zone Lymphoma

BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160))))), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA(r) (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy and granted priority review. The Prescription Drug User Fee Act (PDUFA) target action date is September 19, 2021.