TECENTRIQ (Roche Products Pty Ltd)
Product name
TECENTRIQ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
217 working days (255)
Active ingredients
atezolizumab
Registration type
EOI
Indication
Urothelial carcinoma
TECENTRIQ is now also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who
- are considered cisplatin ineligible and whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥ 5% of the tumour area), as determined by a validated test, or
- are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumor PD-L1 expression.