The United States Food and Drug Administration (FDA) has approved United States-based Merck's Keytruda, intended to treat patients with Bacillus Calmette-Guerin (BCG), unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC), it was reported yesterday.

The product has been approved to treat patients with BCG -unresponsive, high-risk NMIBC - unresponsive, high-risk non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have chosen not to undergo cystectomy. It is a humanised monoclonal antibody that inhibits the interaction between PD-1 and its ligands, PD-L1 and PD-L2, resulting in the activation of T lymphocytes that is likely to affect both tumour cells and healthy cells.

The product has received approval for the new indication based on data from KEYNOTE-057 multicentre, open-label and single-arm trial that hired 96 patients with BCG -unresponsive NMIBC.