By Colin Kellaher

 

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

The Kenilworth, N.J., drugmaker said the recommendation covers Keytruda in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 with a combined positive score of at least 10 and who haven't received prior chemotherapy for metastatic disease.

Merck said the recommendation is based on results from a Phase 3 study in which Keytruda in combination with chemotherapy significantly improved progresion-free and overall survival compared to chemotherapy alone.

The European Commission, which generally follows CHMP's advice, will now review the recommendation.

Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is approved in numerous indications across a range of cancers.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

September 17, 2021 07:49 ET (11:49 GMT)

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