ODAC asks FDA to retain Tecentriq, Keytruda accelerated approvals for bladder cancer  

FDA’s ODAC on Wednesday told FDA to look past postmarket trials that failed to verify clinical benefit and maintain two accelerated approvals for immunotherapies as frontline options for urothelial cancer, citing clinical experience and a lack of alternatives. 

The Oncologic Drugs Advisory Committee voted 5 to 3 to retain accelerated approval for Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status...