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Merck Gets Positive CHMP Opinion For Keytruda Plus Chemotherapy For Triple-Negative Breast Cancer

Merck & Co., Inc. (MRK) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer or TNBC in adults whose tumors express PD-L1 and who have not received prior chemotherapy for metastatic disease.

The positive opinion is based on progression-free survival and overall survival results from the Phase 3 KEYNOTE-355 trial, which showed that treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin), as compared to chemotherapy alone, significantly improved progression-free survival and overall survival in these patient.

Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen hormone receptors, progesterone hormone receptors and overexpression of human epidermal growth factor receptor 2 (HER2). It is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis.

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