Gilead Sciences Says EMA Recommends Trodelvy-Keytruda Combination for Breast Cancer

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Gilead Sciences (GILD) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for Trodelvy in combination with Merck's (MRK) Keytruda for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer.

The recommendation covers patients who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score of at least 10, the company said.

The recommendation is based on data from the phase 3 study, which showed statistically significant and clinically meaningful progression-free survival for Trodelvy plus Keytruda compared with standard of care chemotherapy plus Keytruda.

The European Commission is expected to decide later this year, the company said.

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