BeiGene, Ltd. (BGNE) has announced that the European Commission has granted approval for Tevimbra in combination with chemotherapy as a first-line treatment for esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
Tevimbra is already authorized within the European Union for patients with ESCC who have previously received platinum-based chemotherapy, as well as for three non-small cell lung cancer (NSCLC) indications, applicable in both first- and second-line treatments.
The extended approval for ESCC is supported by the findings from BeiGene's RATIONALE-306 Phase 3 study. This research assessed Tevimbra as a first-line therapy for individuals with unresectable, locally advanced, recurrent, or metastatic ESCC. The study demonstrated that Tevimbra combined with chemotherapy lowered the risk of mortality by 34% compared to a placebo.
For the approval in first-line G/GEJ cancer, the decision was based on the results of the RATIONALE-305 Phase 3 study, where the combination of Tevimbra and chemotherapy resulted in a 29% reduction in the risk of death.
