BeiGene (NASDAQ: BGNE) has announced the submission of a supplementary Biologic License Application in China for its programmed death-1 (PD-1) inhibitor, tislelizumab. The company is seeking regulatory approval for a new indication in the perioperative (neoadjuvant + adjuvant) treatment of patients with resectable non-small cell lung cancer (NSCLC). The Center for Drug Evaluation (CDE) has accepted the filing for review.
The application is supported by the positive results of the RATIONALE 315 study, a Phase III, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tislelizumab in combination with chemotherapy as neoadjuvant therapy, followed by tislelizumab or placebo as adjuvant therapy. The study demonstrated that the combination of tislelizumab and chemotherapy significantly improved the major pathological response (MPR) rate (56.2% vs 15.0%) and pathological complete response (pCR) rate (40.7% vs 5.7%) compared to placebo combined with chemotherapy. The overall tolerability was favorable, with no new safety signals identified.
To date, BeiGene has submitted 15 indication approval filings for tislelizumab to China’s CDE, with 12 of these indications already approved. Of these, 11 are included in the National Reimbursement Drug List (NRDL), highlighting the drug’s significant impact on patient access and treatment options in China.- Flcube.com
