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.
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