BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the U.S. 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) 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.
https://finance.yahoo.com/news/beigene-announces-pdufa-goal-date-110000532.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.