Merck Gains Keytruda Full Approval in Bladder Cancer

FDA has converted Merck’s accelerated approval to full approval for its anti-PD-1 Keytruda (pembrolizumab) and its use in first-line treatment of advanced urothelial carcinoma (bladder cancer). In addition, the indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy, according to the company. Previously, it was indicated for treating certain patients with locally advanced or mUC who were not eligible for cisplatin-containing chemotherapy.
 

Merck says Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.