Gilead Sciences (NASDAQ: GILD) Received European Commission Marketing Authorization Monday August 24, 2026 for Trodelvy (Sacituzumab Govitecan-Hziy, an Anti-Trop-2 Antibody-Drug Conjugate Delivering the SN-38 Topoisomerase I Inhibitor Payload) in Combination With Keytruda (Pembrolizumab) for First-Line Treatment of Adults With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) With PD-L1 CPS ≥10 and No Prior Systemic Therapy for Metastatic Disease; Positioning as the First and Only Antibody-Drug Conjugate Plus Immunotherapy Combination Approved for First-Line Metastatic TNBC in the EU's 27 Member States Plus Norway, Iceland, and Liechtenstein; The Approval Extends Gilead's ADC Commercial Franchise and Adds to the ADC Combination-Therapy Category That Is Attracting Increasing Investment Across Oncology
Gilead Sciences (NASDAQ: GILD) received European Commission marketing authorization Monday August 24, 2026 for Trodelvy (sacituzumab govitecan-hziy) in combination with Keytruda (pembrolizumab) for first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Approval criteria: PD-L1 combined positive score (CPS) ≥10 and no prior systemic therapy for metastatic disease. Trodelvy mechanism: an antibody-drug conjugate (ADC) with an anti-Trop-2 monoclonal antibody linked to the SN-38 topoisomerase I inhibitor payload; when Trop-2 (trophoblast cell surface antigen 2) is expressed on tumor cells, Trodelvy binds and internalizes to release the cytotoxic SN-38 inside the cancer cell. The Keytruda addition provides checkpoint inhibitor activity against PD-L1-positive tumors. Positioning: the first and only antibody-drug conjugate plus immunotherapy combination approved for first-line metastatic TNBC in the EU's 27 member states, plus Norway, Iceland, and Liechtenstein. The FDA had already approved the same combination in June 2026 based on the same clinical evidence. The approval extends Gilead's ADC commercial franchise. The ADC combination-therapy category (ADC + checkpoint inhibitor, ADC + targeted therapy) has attracted increasing investment across oncology as ADCs establish clinical value across breast, bladder, lung, and other solid tumors; adjacent peptide-drug conjugates (PDCs) with tumor-targeting peptides plus cytotoxic payloads are also expanding as a related modality.