trending Market Intelligence /marketintelligence/en/news-insights/trending/jMFnyJWE-52Wx_THt8qfnw2 content
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

In This List

US FDA panel backs Merck & Co.'s Keytruda to treat type of bladder cancer

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform

US FDA panel backs Merck & Co.'s Keytruda to treat type of bladder cancer

A panel of outside advisers to the U.S. Food and Drug Administration voted 9 to 4 in favor of approving Merck & Co. Inc.'s blockbuster drug, Keytruda, for the treatment of high-risk, non-muscle invasive bladder cancer.

Keytruda, or pembrolizumab, is a checkpoint inhibitor — a tumor-targeting drug that blocks the PD-1 arm on healthy cells from linking up with a partner arm on the surface of cancer cells to spread the disease. The drug is already approved in the U.S. in multiple cancer indications.

SNL Image

During a Dec. 17 meeting, the majority of the Oncologic Drugs Advisory Committee voted that Keytruda, which is under a priority review by the FDA for treatment of high-risk, non-muscle invasive bladder cancer that has carcinoma in-situ, has the potential to treat the disease in patients who have limited nonsurgical treatment options.

Initial results from a phase 2 study, dubbed Keynote-057, showed that 38.8% of bladder cancer patients who received Keytruda in a mid-stage trial had no detectable cancer at three months.

According to Merck & Co.'s Dec. 17 press release, more than 80,000 new cases of bladder cancer will be diagnosed in 2019 in the U.S. and about 75% of bladder cancer patients have non-muscle invasive bladder cancer.

The FDA is set to decide on Keytruda's additional approval in January 2020. The U.S. regulator is not required to take the advisory committee's recommendation.