FDA Adds PD-L1 Expression to Frontline Pembrolizumab, Atezolizumab Urothelial Carcinoma Labels

June 20, 2018 – The FDA has incorporated PD-L1 status into the labels for pembrolizumab and atezolizumab for existing frontline approvals for platinum-ineligible patients with urothelial carcinoma, based on lower overall survival (OS) rates with the PD-1/PD-L1 inhibitors compared with platinum-based chemotherapy for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma. “In patients already receiving Keytruda or Tecentriq who are responding to … (leggi tutto)