Posted by Michael Wonder on 13 Jun 2022
BeiGene announces PDUFA goal date extension for U.S. sNDA for Brukinsa for the treatment of CLL/SLL
13 June 2022 - Following additional data submission to FDA demonstrating ORR superiority over ibrutinib as determined by IRC, PDUFA goal date extended to 20 January 2023 to allow time for review.
BeiGene today announced that the U.S. FDA has extended the Prescription Drug User Fee Act goal date by three months to January 20, 2023 for the supplementary new drug application for Brukinsa as a treatment for adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma.
