November 20, 2025

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

IntelME Verdict

Regulatory Approval

TL;DR

BeiGene's Tevimbra (tislelizumab) obtained European Commission approval on 15/09/2023 for various cancers, showing improved survival rates in Phase 3 trials.

Analysis

BeiGene's Tevimbra (tislelizumab) gaining European Commission approval for multiple cancers signifies a significant regulatory milestone. The expanded label and improved survival rates in Phase 3 trials highlight its potential to address unmet medical needs, offering new treatment options for patients and positioning BeiGene competitively in the oncology market.