BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced a delay in the U.S. FDA’s decision on its Biologics License Application (BLA) for tislelizumab (Baizean), a PD-1 inhibitor, citing the agency’s inability to conduct onsite inspections. The BLA, filed in September 2021, sought approval for second-line treatment of esophageal squamous cell carcinoma (ESCC).
FDA’s Stance
The FDA deferred action on the application due to travel restrictions preventing inspections, with no new PDUFA date set. Notably, the agency did not issue a Complete Response Letter (CRL), which analysts view as a positive sign for eventual approval.
Clinical Data
The BLA was supported by the RATIONALE 302 Phase III trial, involving 512 patients across Europe, the U.S., and Asia. Results showed tislelizumab reduced the risk of death by 30% (HR=0.70, p=0.0001) and extended median overall survival by 2.3 months vs. chemotherapy.
Comparison with Junshi Biosciences
Junshi Biosciences faced a similar delay for its PD-1 inhibitor toripalimab earlier this year but was required to refile its BLA due to quality control changes. BeiGene emphasized its partnership with Novartis to facilitate inspections and secure U.S. approval.-Fineline Info & Tech
