Posted by Michael Wonder on 19 May 2021
BeiGene announces U.S. FDA acceptance and priority review of supplemental new drug application for Brukinsa (zanubrutinib) in marginal zone lymphoma
19 May 2021 - BeiGene today announced that the U.S. FDA has accepted a supplemental new drug application for Brukinsa (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20 based therapy and granted priority review.
The Prescription Drug User Fee Act target action date is 19 September 2021.
