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EU Approves Merck's Keytruda Plus Chemotherapy To Treat Triple-Negative Breast Cancer

The European Commission has approved Merck & Co. Inc.'s (MRK) anti-PD-1 therapy, Keytruda, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 and who have not received prior chemotherapy for metastatic disease, the company said in a statement on Friday.

The approval allows marketing of the combination with Keytruda in all 27 European Union member states plus Iceland, Lichtenstein, Norway and Northern Ireland.

Triple-negative breast cancer is an aggressive type of breast cancer. It represents Keytruda's first approval in Europe in a breast cancer setting.

The approval was based on final analysis from the Phase 3 KEYNOTE-355 trial, in which Keytruda in combination with chemotherapy significantly improved overall survival, reducing the risk of death by 27%, and progression-free survival, reducing the risk of disease progression or death by 34% compared to chemotherapy alone in these patients.

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