Shots:

• The approval is based on the P-III (RATIONALE 303) trial to evaluate tislelizumab vs docetaxel in a ratio (2:1) in 805 patients with LA or metastatic NSCLC who have progressed on prior Pt-based CT at 10 countries across Asia, EU Americas & Oceania
• The results showed an improvement in OS, was well-tolerated, consistent with known safety risks from previously reported results across different tumors & no new safety signals were observed
• Tislelizumab is a humanized IgG4 anti-PD-1 mAb & marks 3rd approved indication & 1st in previously treated patient population while tislelizumab’s BLA is currently under US FDA’s review for ESCC with an anticipated PDUFA date of July 12, 2022

Ref: Businesswire | Image: BeiGene