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
09-17-21 0749ET