On April 28, 2021, an FDA panel will discuss whether or not to convert the accelerated approval granted to Merck’s (MRK) Keytruda, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, into regular approval.Keytruda for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy was granted accelerated approval by the FDA in May 2017.The accelerated approval was based on results from a single-arm trial of the company, dubbed, KEYNOTE-052, which demonstrated an objective response rate of 29%.However, in another pivotal study, dubbed KEYNOTE-361, whose results were reported in June 2020, it was found that adding Keytruda to chemotherapy did not improve survival in patients with advanced or metastatic urothelial carcinoma. Since the Keytruda combination arm did not demonstrate superiority for the dual primary endpoints of overall survival or progression-free survival, the Keytruda monotherapy arm was not formally tested.MRK closed Friday’s (Mar.26, 2021) trading at $77.39, up 1.74%.