Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Nivolumab in patients with Bladder Urothelial Carcinoma.
The European Medicines Agency (EMA) has authorized nivolumab as a monotherapy for the adjuvant treatment of adult patients with muscle invasive urothelial carcinoma (MIUC) with tumor cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.
This statement is based on a regulatory approval from the European Medicines Agency:
OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.