FDA approves updated indication for Merck’s Keytruda (pembrolizumab) for treatment of certain patients with urothelial carcinoma (bladder cancer)

Merck/MSD

31 August 2021 - Keytruda approved for treatment of patients with locally advanced or metastatic urothelial carcinoma who are Not eligible for any platinum-containing chemotherapy.

Merck today announced a label update for Keytruda for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. The U.S. 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 who are not eligible for any platinum-containing chemotherapy.

Read Merck press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US