BeiGene, Ltd. announced that the Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental biologics license application for tislelizumab in patients with first-line unresectable or metastatic hepatocellular carcinoma. Hepatocellular carcinoma is the most common type of primary liver cancer worldwide and is associated with a very poor prognosis.1 New cases and deaths due to HCC in China account for half of the global numbers and the 5-year survival rate for patients with HCC in China is only 14%. The sBLA is supported by data from the RATIONALE 301 clinical trial that enrolled 674 patients from research centers across Asia, Europe, and the United States.

RATIONALE 301 results were presented as a late-breaking oral presentation at the 2022 European Society for Medical Oncology Congress in Paris. Tislelizumab was approved by the China NMPA as a treatment for nine indications, including conditional approval ‘for the treatment of patients with hepatocellular carcinoma who have been previously treated with at least one systemic therapy'. Additional tislelizumab's sBLAs under review at CDE include: combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1; combination with chemotherapy as first-line treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Tislelizumab is not approved for use outside of China.