BeiGene, Ltd. announced that the U.S. Food and Drug Administration 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 leukemia or small lymphocytic lymphoma. 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 as assessed by an Independent Review Committee 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. The sNDA filing in CLL/SLL includes data from two pivotal randomized Phase 3 studies and eight supportive studies in B-cell malignancies. The two global Phase 3 trials of BRUKINSA in CLL/SLL are: SEQUOIA comparing BRUKINSA to bendamustine and rituximab in treatment-naïve patients and ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in relapsed or refractory (R/R) patients.

Additionally, the SEQUOIA study enrolled patients with deletion 17p in a non-randomized arm evaluating BRUKINSA monotherapy in this high-risk population. ALPINE and SEQUOIA enrolled patients from a total of 17 countries, including the United States, multiple countries in Europe, China, Australia, and New Zealand. Interim results from the ALPINE trial and the SEQUOIA trial were reported at the 26th European Hematology Association Virtual Congress in June 2021 and at the 63rd America n Society for Hematology Annual Meeting in December 2021, respectively.