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Merck & Co.'s Keytruda wins US FDA approval for high-risk bladder cancer

Merck & Co. Inc.'s blockbuster drug Keytruda has been approved by the U.S. Food and Drug Administration to treat a high-risk type of bladder cancer.

The U.S. regulator approved the drug under priority review to treat patients with high-risk, non-muscle invasive bladder cancer that has carcinoma in situ — a group of abnormal cells — and may or may not have papillary tumors.

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For this form of bladder cancer, Keytruda can only be used to treat patients whose disease is unresponsive to the immunotherapy known as Bacillus Calmette-Guerin and are ineligible or chose to not have their bladders surgically removed.

The American Cancer Society estimates that about 81,400 new cases of bladder cancer will be diagnosed in the U.S. in 2020.

The FDA's approval is based on results from a phase 2 study called Keynote-057, which showed that 41% of patients had no detectable cancer, known as a complete response, after being treated with Keytruda.

Among the patients who achieved a complete response, the median duration of response was 16.2 months and 46% had a response of 12 months or longer.

Keytruda is already approved by the FDA for multiple types of cancer and is being tested in more than 1,000 trials across a wide variety of cancers and treatment settings.