BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, for three distinct non-small cell lung cancer (NSCLC) indications.
The approvals allow for the use of tislelizumab in the following scenarios:
- In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC who have locally advanced disease not amenable to surgical resection or platinum-based chemoradiation, or those with metastatic NSCLC.
- In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells, with no EGFR or ALK positive mutations, and who have locally advanced disease not suitable for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
- As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. This includes patients with EGFR mutant or ALK positive NSCLC who have previously received targeted therapies.
The approvals were supported by the results of the RATIONALE 307, 304, and 303 studies, which demonstrated the drug’s safety, tolerability, and significant survival benefits.
BeiGene has submitted 15 indication approvals for tislelizumab to China’s Center for Drug Evaluation (CDE), with 12 receiving the green light and 11 included in the National Reimbursement Drug List (NRDL). In the US, the drug was recently approved to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC) in patients previously treated with systemic chemotherapy without prior PD-(L)1 inhibitor treatment.- Fineline.com
