On 4 March 2025, BeiGene announced that the US FDA has approved its Tevimbra® (tislelizumab), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) whose tumours express PD-L1 (≥1).
Tevimbra® has received a number of indication extensions in the past few months, including:
- in the US, in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal (G/GEJ) adenocarcinoma (January 2025); and
- in Australia, in combination with platinum-based chemotherapy, for the first-line treatment of patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (December 2024).
In December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) recommended PBS-listing of Tevimbra® for oesophageal squamous cell carcinoma. In the same month, BeiGene announced New Zealand approval of Tevimbra® in various monotherapy and combination therapy indications. Tevimbra® also recently received EU approval as combination therapy with chemotherapy for the first-line treatment of oesophageal squamous cell carcinoma and G/GEJ adenocarcinoma (November 2024).