![]() ![]() ![]() Javier Cortés, head of the International Breast Cancer Center (IBCC), Quironsalud Group. “This approval is an important milestone for appropriate patients with metastatic TNBC who are in need of new treatment options,” said Dr. In this trial, 38% of enrolled patients had tumors expressing PD-L1 with CPS ≥10. The approval is based on final analysis from the Phase 3 KEYNOTE-355 trial, in which KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) significantly improved overall survival (OS), reducing the risk of death by 27% (HR=0.73 p=0.0093), and progression-free survival (PFS), reducing the risk of disease progression or death by 34% (HR=0.66 p=0.0018) compared to chemotherapy alone in these patients. This represents KEYTRUDA’s first approval in Europe in a breast cancer setting. Triple-negative breast cancer is an aggressive type of breast cancer. KENILWORTH, N.J.-( BUSINESS WIRE)-Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score ≥10) and who have not received prior chemotherapy for metastatic disease. ![]()
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