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

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Merck's Keytruda wins U.S. FDA approval for bladder cancer
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The U.S. Food and Drug Administration said on Wednesday it approved Merck & Co I...

FILE PHOTO: The Merck logo is seen at a gate to the Merck & Co campus in Linden, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File Photo

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 the bladder. “This is the first time that we’re recognizing that systemic immune activation can lead to durable remission of cancer,” said Dr. Arjun Balar of NYU Langone’s Perlmutter Cancer Center, the study’s lead investigator.

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 treatment options other than surgery, which comes with substantial risk of complications, hospitalizations, and even death.

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