By Colin Kellaher


Merck & Co. on Thursday said the U.S. Food and Drug Administration accepted its application for expanded use of its blockbuster cancer drug Keytruda in combination with chemotherapy in patients with locally advanced unresectable or metastatic biliary tract cancer.

The Kenilworth, N.J., drugmaker said the application is based on data from a Phase 3 study in which the combination showed a statistically significant improvement in overall survival compared to chemotherapy alone.

Merck said the FDA set a target action date of Feb. 7, 2024, for the application.

Biliary tract cancer, a group of rare and highly aggressive cancers in the gallbladder and bile ducts, accounts for about 15% of all liver cancers.

Merck is studying Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, in a raft of trials across a wide variety of cancers and treatment settings. The drug, which is approved in dozens of indications worldwide, generated sales of nearly $21 billion last year.


Write to Colin Kellaher at


(END) Dow Jones Newswires

June 08, 2023 07:27 ET (11:27 GMT)

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