Merck Gets FDA Priority Review of Keytruda in Head, Neck Cancer
2019年2月11日 - 9:32PM
Dow Jones News
By Colin Kellaher
Merck & Co. (MRK) on Monday said the U.S. Food and Drug
Administration accepted and granted priority review for a
supplemental biologics license application for the cancer drug
Keytruda in head and neck cancer.
The Kenilworth, N.J., drug maker said the sBLA seeks approval
for Keytruda as monotherapy or in combination with chemotherapy for
the first-line treatment of patients with recurrent or metastatic
head and neck squamous cell carcinoma.
Merck said the sBLA filing is partly based on data from a phase
3 study in which Keytruda showed a significant improvement in
overall survival compared with the standard of care.
The FDA set a target action date of June 10, Merck said.
Keytruda, a cancer drug that harnesses a patient's 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
February 11, 2019 07:17 ET (12:17 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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