EC Approves BeiGene's Tevimbra For First-Line Treatment Of ESCC And G/GEJ Cancer

(RTTNews) - BeiGene, Ltd. (BGNE), Wednesday said that the European Commission has approved Tevimbra in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

Tevimbra is already approved in the EU for eligible patients with ESCC after prior platinum-based chemotherapy and for three NSCLC indications covering both the first- and second-line settings.

In ESCC, expanded approval was based on results from BeiGene's RATIONALE-306 Phase 3 study, which evaluated Tevimbra as a first-line treatment in patients with unresectable, locally advanced recurrent or metastatic ESCC. Results from the study showed that Tevimbra plus chemotherapy reduced risk of death by 34 percent compared to placebo.

The approval of Tevimbra in first-line G/GEJ cancer was based on results from RATIONALE-305 Phase 3 study, in which Tevimbra in combination with chemotherapy reduced risk of death by 29 percent.