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%.