TECENTRIQ (Roche Products Pty Ltd)
Product name
TECENTRIQ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
69 working days (255)
Active ingredients
atezolizumab
Registration type
EOI
Indication
Triple-negative breast cancer
TECENTRIQ (concentrated solution for injection), in combination with paclitaxel protein-bound, is now also indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumour), as determined by a validated test and who have not received prior chemotherapy for metastatic disease.This indication is approved under provisional approval based on progression free survival. Continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial(s).
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration