BeiGene’s biologics license application for Tevimbra (tislelizumab) for first-line gastric or gastro-oesophageal junction cancers accepted by FDA

BeiGene

27 February 2024 - Application based on results from global Phase 3 RATIONALE-305 trial demonstrating Tevimbra plus chemotherapy significantly improved overall survival in advanced gastric/GEJ cancer.

BeiGene today announced that the US FDA has accepted a biologics license application for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma.

Read BeiGene press release 

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier