On 6 January 2025, the Australian Therapeutic Goods Administration (TGA) approved an indication expansion for BeiGene’s Tevimbra® (tislelizumab) in combination with platinum-based chemotherapy for the first-line treatment of patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma.
This comes shortly after BeiGene’s announcement, on 27 December 2024, that the US FDA has approved Tevimbra® 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.
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).