TEVIMBRA (Beigene Aus Pty Ltd)
Product name
TEVIMBRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
228 (255 working days)
Active ingredients
tislelizumab
Registration type
NCE/ NBE
Indication
TEVIMBRA in combination with platinum-based chemotherapy is indicated for the firstline treatment of patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma with a PD-L1 expression ≥ 1% as determined by a validated test.