Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 >= 5% status confers therapeutic sensitivity to Atezolizumab in patients with Bladder Urothelial Carcinoma.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.