Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized atezolizumab for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are considered cisplatin ineligible, and whose tumors have PD-L1 expression >= 5%.

This is written in the approval document as:

Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC (i) after prior platinum-containing chemotherapy, or (ii) who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression >= 5%.

Citation

Roche Registration GmbH. Tecentriq (atezolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf. Revised March 2024. Accessed March 23, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 5%	Bladder Urothelial Carcinoma	Atezolizumab