Pembrolizumab: FDA Grants Curtailed mUC Full Approval

Today the FDA announced the full approval of pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. The full approval conversion limits the use of pembrolizumab to a smaller subset of patients in the 1L setting (platinum ineligible) vs. the previous accelerated approval; which was in PD-L1+ cisplatin-ineligible patients. The limitation is a result of pembrolizumab failing a confirmatory study in this setting.