Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10).
Trodelvy plus Keytruda is the first and only antibody-drug conjugate (ADC) plus immunotherapy combination to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.
This decision follows the recent EC approval of Trodelvy as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Together, these approvals establish Trodelvy as the backbone therapy for patients with first-line metastatic TNBC across PD-L1 status in Europe. This decision provides a new treatment option for the most aggressive form of breast cancer at the first sign of metastatic disease.