Merck's Keytruda wins U.S. FDA approval for bladder cancer

(Reuters) - The U.S. Food and Drug Administration said on Wednesday it approved Merck & Co Inc’s Keytruda for a hard-to-treat form of bladder cancer.

The therapy was approved for patients with a high-risk non-muscle invasive bladder cancer who have undergone prior treatment and are ineligible for or have opted out of surgical removal of part of the bladder.

Non-muscle-invasive bladder cancer is commonly treated with the Bacillus Calmette-Guerin vaccine. However, patients who do not respond to the vaccine have limited non-surgical treatment options.

The approval was based on results from a mid-stage study in which nearly 41% of the patients on Keytruda showed a complete response, with about half of them having a complete response for at least a year.

Merck estimated that more than 80,000 Americans were newly diagnosed with bladder cancer over the last year, of which more than three fourths of patients were expected to have non-muscle-invasive bladder cancer.

Keytruda is already approved for treating a number of cancers including melanoma, lung cancer, head and neck cancer and Hodgkin lymphoma.

JANUARY 8, 2020

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