European Commission approves Trodelvy plus Keytruda for first-line PD-L1-positive metastatic triple-negative breast cancer

The approval establishes Trodelvy-based treatment across PD-L1 status in first-line metastatic TNBC in Europe, following the earlier authorisation of Trodelvy monotherapy for patients not eligible for PD-1/PD-L1 inhibitors.

The European Commission has approved Gilead’s Trodelvy (sacituzumab govitecan) in combination with Keytruda (pembrolizumab) for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received no prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥10.

The authorisation makes the combination the first ADC plus immunotherapy regimen approved for first-line metastatic TNBC in the EU and, together with the earlier Trodelvy monotherapy approval, provides Trodelvy-based options across PD-L1 status.

Field	Content
Alert Type	Drug Approval
Drug Name	Trodelvy (sacituzumab govitecan), in combination with Keytruda (pembrolizumab)
Indication	Treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with CPS ≥10. (Gilead Sciences Investor Relations)
Therapy Area(s)	Oncology; Breast cancer
Geography	European Union; Norway; Iceland; Liechtenstein
What Happened	On 24 August 2026, the European Commission granted marketing authorisation for Trodelvy in combination with Keytruda for first-line treatment of PD-L1-positive unresectable locally advanced or metastatic TNBC. The approval follows a positive CHMP opinion issued in July and is based on the Phase III ASCENT-04/KEYNOTE-D19 study. It follows a separate June 2026 European approval of Trodelvy monotherapy for first-line metastatic TNBC in adults who are not candidates for PD-1 or PD-L1 inhibitor therapy. (Gilead Sciences Investor Relations)
Why It Matters	The decision moves Trodelvy into first-line treatment for PD-L1-positive metastatic TNBC in combination with immunotherapy. Together with the existing monotherapy indication for patients who are not candidates for PD-1/PD-L1 inhibitors, the approvals establish Trodelvy-based first-line options across PD-L1 status in Europe and move the ADC substantially earlier in the metastatic treatment pathway. (Gilead Sciences Investor Relations)
Supporting Context	The approval is supported by ASCENT-04/KEYNOTE-D19, which compared Trodelvy plus Keytruda with standard-of-care chemotherapy plus Keytruda in first-line PD-L1-positive metastatic TNBC. The Trodelvy combination produced a statistically significant improvement in progression-free survival, reducing the risk of disease progression or death by 35% versus the comparator regimen. (Gilead Sciences Investor Relations)
Key Takeaway	The European approval establishes Trodelvy plus Keytruda as a new first-line option for PD-L1-positive metastatic TNBC and completes Trodelvy’s expansion across PD-L1 status in the European first-line setting.
What to Watch	Adoption of Trodelvy-based regimens in European first-line metastatic TNBC and how clinicians position the ADC plus Keytruda against existing chemotherapy-immunotherapy approaches for PD-L1-positive disease.
Primary Source	Gilead Sciences – European Commission marketing authorisation announcement (Gilead Sciences Investor Relations)
Relevant Date	24 August 2026

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