November 20, 2025

Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 15, Status: Authorised

IntelME Verdict

Clinical Breakthrough

TL;DR

BeiGene's Tevimbra (tislelizumab), an anti-PD-1 monoclonal antibody, received European Commission approval for various cancers with improved survival benefits over chemotherapy.

Analysis

The European approval of Tevimbra (tislelizumab) for various cancers signifies a significant advancement in treatment options, offering improved survival benefits over traditional chemotherapy. Medical professionals can now consider this anti-PD-1 monoclonal antibody as a valuable addition to their armamentarium for managing unresectable or metastatic cancers, potentially enhancing patient outcomes.