On 27 November 2024, BeiGene announced that the European Commission approved Tevimbra® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Tevimbra® was previously EU approved for unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy and for three NSCLC indications covering both the first- and second-line settings (April 2024).
This news follows recommendation of these new indications by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2024. BeiGine has also sought Australian approval of Tevimbra® for the treatment of recurrent or metastatic nasopharyngeal carcinoma (July 2024).