BeiGene (ONC) said Tuesday the US Food and Drug Administration approved Tevimbra, in combination with platinum-containing chemotherapy, for the first-line treatment of certain adults with unresectable or metastatic esophageal squamous cell carcinoma.
The company said the approval is based on a phase 3 study where Tevimbra combination therapy showed a statistically significant improvement in overall survival.
Tevimbra is also approved in the US as monotherapy for some patients with esophageal squamous cell carcinoma and in combination with chemotherapy for the first-line treatment of adults with gastric and gastroesophageal junction cancers, it added.
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