Full FDA approval for Keytruda in bladder cancer

Merck & Co (NYSE: MRK) has announced a label update for Keytruda (pembrolizumab), the US pharma giant’s blockbuster anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the USA. The drug notched up first-half sales of over $8 billion.

The US Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. In addition, as part of the label update, this 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.

Previously, Keytruda was indicated for the treatment of patients with locally advanced or mUC who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.