Merck's Keytruda Gets FDA Priority Review in Liver Cancer
July 11 2018 - 7:47AM
Dow Jones News
By Colin Kellaher
Merck & Co. (MRK) on Wednesday said the Food and Drug
Administration accepted and granted priority review for a new
supplemental Biologics License Application seeking approval for
Keytruda in advanced liver cancer.
The Kenilworth, N.J., drug maker said the sBLA seeks accelerated
approval for Keytruda as a treatment for previously treated
patients with advanced hepatocellular carcinoma. The FDA has set a
target action date of Nov. 9, Merck said.
Hepatocellular carcinoma is the most common type of liver cancer
in adults, Merck said. An estimated 42,200 new cases of liver
cancer will be diagnosed in the U.S. this year.
Keytruda, a new type of cancer drug that harnesses patients'
immune systems to fight tumors, is already marketed to treat lung,
skin, bladder and other cancers.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 11, 2018 07:32 ET (11:32 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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