BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has revealed that a supplementary Biologic License Application (sBLA) for its programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the National Medical Products Administration (NMPA). The latest prospective indication is for the drug’s use in first-line unresectable or metastatic hepatocellular carcinoma (HCC), marking the 12th regulatory filing for the drug in China.
Previously Approved Indications
Tislelizumab has previously been approved for nine indications in China, including both squamous and non-squamous cell non-small cell lung cancer (sq/nsq NSCLC) in combination with chemotherapy and as a monotherapy for second-or third-line NSCLC. Conditional approvals have also been awarded by the NMPA for tislelizumab as a third-line treatment for classical Hodgkin’s lymphoma (cHL), metastatic urothelial carcinoma (UC), second-line therapy for HCC, unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, second-line for esophageal squamous cell carcinoma (ESCC), and as a first-line therapy for nasopharyngeal carcinoma (NPC).
Ongoing Approval Filings
Currently, approval filings were made in June and August 2022 for tislelizumab in combination with chemotherapy in the first-line treatment for gastric or gastroesophageal junction (GC/GEJ) adenocarcinoma and for first-line ESCC, respectively. These ongoing filings further expand the potential applications of tislelizumab in addressing significant unmet medical needs in various cancer types.-Fineline Info & Tech
