Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 (CPS) >= 10 status confers therapeutic sensitivity to Pembrolizumab in patients with Bladder Urothelial Carcinoma.
The European Medicines Agency (EMA) has authorized pembrolizumab as a monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 with a combined positive score (CPS) >= 10.
This statement is based on a regulatory approval from the European Medicines Agency:
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) >= 10.