By Colin Kellaher


Merck & Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its blockbuster cancer drug Keytruda in certain patients with biliary tract cancer.

The Rahway, N.J., drugmaker said the recommendation covers Keytruda in combination with gemcitabine and cisplatin for the first-line treatment of adults with locally advanced unresectable or metastatic biliary tract carcinoma.

Merck said the positive CHMP opinion is based on results from a phase 3 study in which the Keytruda combination showed a statistically significant improvement in overall survival versus chemotherapy alone.

The European Commission, which generally follows the CHMP's advice, is expected to make a decision by the end of the year, Merck said.

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 more than $18 billion in the first nine months of 2023.


Write to Colin Kellaher at


(END) Dow Jones Newswires

November 10, 2023 08:20 ET (13:20 GMT)

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