FDA restrictions on Keytruda and on Tecentriq for bladder cancer.

The FDA has restricted use of Keytruda (pembrolizumab) from Merck Inc.and Tecentriq (atezolizumab) from Roche among patients with locally advanced or metastatic bladder cancer who are not eligible for cisplatin-containing chemotherapy. Within that group, Keytruda is now approved only for patients whose tumors express levels of the biomarker PD-L1 that meet a combined positive score of 10 or higher. Tecentriq can only be used for those whose PD-L1 immune cells cover 5% or more of their tumor area. The FDA stated that patients who are not eligible for any platinum-containing therapy can still take either drug, regardless of their PD-L1 status.