CHMP recommends approval for BeiGene’s tislelizumab in ESCC treatment

BeiGene, a global biotechnology firm, has revealed that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for tislelizumab.

This treatment is intended for adult patients suffering from unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone platinum-based chemotherapy.

“Tislelizumab is the first medicine to come from BeiGene’s immuno-oncology research program and our team partnered with patients, caregivers, and clinical researchers across the world to generate the evidence supporting this CHMP recommendation,” commented Lai Wang, Global Head of R&D at BeiGene.

The Marketing Authorization Application (MAA) for ESCC rests on the findings from BeiGene’s RATIONALE 302 study, a global, randomized, open-label, Phase 3 study investigating the efficacy and safety of tislelizumab in comparison with the investigator’s choice chemotherapy as a second-line treatment for ESCC patients.

The trial showed a significant survival benefit for tislelizumab compared with chemotherapy. Tislelizumab, which is not yet authorized for use in Europe, is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to aid immune cells in the detection and combat against tumors.

In 2021, BeiGene and Novartis formed a partnership to co-develop tislelizumab in several countries, with Novartis responsible for regulatory submissions and commercialization following regulatory approval.