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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.
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(END) Dow Jones Newswires
February 11, 2019 07:17 ET (12:17 GMT)
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