On October 21, 2024, BeiGene announced that 百泽安 (tislelizumab), its anti-PD-1 monoclonal antibody, had been officially approved by the National Medical Products Administration (NMPA) of China for neoadjuvant therapy in combination with platinum-containing chemotherapy, followed by single-agent adjuvant therapy with tislelizumab after surgery, for the treatment of patients with resectable stage II or IIIA non-small cell lung cancer (NSCLC).
As the first PD-1 drug approved in China for neoadjuvant plus adjuvant immunotherapy for stage II–IIIA non-small cell lung cancer (NSCLC), tislelizumab offers a new option for perioperative treatment of patients with operable lung cancer, helping patients achieve greater survival benefits.
Basis for This Approval
This approval is supported by clinical data from RATIONALE 315, a multicenter, randomized, placebo-controlled, double-blind Phase III trial. The study evaluated the efficacy and safety of neoadjuvant therapy with tislelizumab plus platinum-based doublet chemotherapy, followed by adjuvant therapy with tislelizumab, in patients with resectable stage II or IIIA NSCLC.
Disease Background
Surgery remains the mainstay treatment for early, intermediate and locally advanced non-small cell lung cancer. Neoadjuvant and adjuvant therapy before and after surgery play a critical role in reducing the risk of cancer recurrence and further improving cure rates. We believe that the approval of this new indication for tislelizumab will further strengthen confidence in the clinical practice of perioperative immunotherapy, bringing greater hope of cure to numerous lung cancer patients.
As of October 21, 2024, tislelizumab has been approved for 14 indications by the NMPA in China, among which 11 indications have been included in the National Reimbursement Drug List (NRDL). It is currently the PD-1 inhibitor with the largest number of approved indications covered by the National Reimbursement Drug List.
