Posted by Michael Wonder on 22 Jul 2023
BeiGene announces positive CHMP opinion for tislelizumab as a treatment for advanced or metastatic oesophageal squamous cell carcinoma
21 July 2023 - BeiGene today announced that the CHMP of the EMA has issued a positive opinion recommending approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.
The marketing authorisation application for oesophageal squamous cell carcinoma is based on results from BeiGene’s RATIONALE 302, a global, randomised, open-label, Phase 3 study to investigate the efficacy and safety of tislelizumab when compared with investigator’s choice chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma.
