Yesterday, Merck & Co. (MSD) announced that the US FDA has approved an updated label for the anti-PD-1 therapy Keytruda for the first-line treatment of advanced urothelial cancer (bladder cancer). The US FDA has shifted the indication from accelerated approval to full approval. In addition, the indication was revised to be used for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) patients who are not suitable for any platinum-containing chemotherapy regimens.

Previously, Keytruda was indicated for the treatment of locally advanced or mUC patients who are not suitable for cisplatin-containing chemotherapy and whose tumors express PD-L1 ([CPS]≥10), or are not suitable for any platinum-containing chemotherapy (regardless of the status of PD-L1) Of patients. Based on the tumor remission rate and duration of remission, this indication has been granted accelerated approval.

The subsequent phase 3 trial KEYNOTE-361 evaluated the effect of Keytruda as a single-agent therapy in combination with chemotherapy in the first-line treatment of patients with advanced or mUC who are suitable for platinum-containing chemotherapy. Compared with standard chemotherapy, Keytruda did not meet the pre-specified dual primary endpoint of overall survival or progression-free survival.

The label update follows the U.S. FDA Oncology Drug Advisory Committee (ODAC) meeting held earlier this year as part of an accelerated approval evaluation for industry-wide failure to meet post-marketing requirements. Members voted (5-3) in favor of maintaining the accelerated approval of Keytruda's first-line bladder indication.