Regulatory approval

Published by the European Medicines Agency. Approved

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%.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	PD-L1 >= 5%	Bladder Urothelial Carcinoma	Atezolizumab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2018-07-02	European Medicines Agency	Indication received approval from the European Commission.