FDA delays PDUFA date for BeiGene Brukinsa sNDA; MENA distribution deal

Biotech BeiGene (HKEX: 06160) has announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to January 20, 2023 for the supplementary new drug application (sNDA) submitted for Brukinsa as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The FDA extended the PDUFA goal date to allow time to review additional clinical data submitted by BeiGene, which was deemed a major amendment to the sNDA. The submission included final response analysis from the global ALPINE clinical trial showing Brukinsa demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) CLL or SLL. This final response analysis was  announced by the company on April 11, 2022.

“We will continue to work closely with the FDA to facilitate the review of our sNDA for Brukinsa in CLL/SLL,” said John Oyler, co-founder, chairman and chief executive of BeiGene. “We are confident that the data in our filing demonstrate Brukinsa’s potential in  the treatment of CLL/SLL and are committed to bringing this important medicine to CLL/SLL patients in the US as soon as possible following regulatory approval,” he added.