Merck Gets CHMP Backing of Keytruda in Triple-Negative Breast Cancer
September 17 2021 - 8:04AM
Dow Jones News
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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