Pembrolizumab and atezolizumab USPIs updated by FDA
On the 16th of August, 2018, the FDA updated the prescribing information for pembrolizumab (Keytruda®, Merck) and atezolizumab (Tecentriq®, Roche/Genentech) and added the requirement for the use of an FDA-approved companion diagnostic test (CDx) to determine PD-L1 levels in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.