Gilead wins EU approval for Trodelvy combo

• Gilead Sciences received European Commission approval for Trodelvy plus Keytruda to treat adults with PD-L1-positive metastatic triple-negative breast cancer.
• The approval covers the European Union’s 27 member states, Norway, Iceland, and Liechtenstein.
• Gilead stated that the approval was supported by Phase 3 ASCENT-04/KEYNOTE-D19 data showing a 35% reduction in the risk of disease progression or death.

Gilead Sciences (NASDAQ:GILD) announced that the European Commission approved Trodelvy (sacituzumab govitecan-hziy) combined with Keytruda (pembrolizumab) for adults with PD-L1-positive metastatic triple-negative breast cancer.

The approval applies to patients with unresectable, locally advanced, or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and whose tumors have a PD-L1 combined positive score of at least 10.

The decision was based on the Phase 3 ASCENT-04/KEYNOTE-D19 study, which showed Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% compared with standard chemotherapy plus Keytruda in the evaluated patient group.

Gilead stated that the approval expands Trodelvy-based treatment options in first-line metastatic TNBC.

Trodelvy is now approved in the European Union for first-line metastatic TNBC patients across different PD-L1 treatment eligibility groups, following a previous approval for patients who are not candidates for PD-1 or PD-L1 inhibitor therapy.

Gilead Sciences develops medicines across oncology, HIV, liver disease, and other therapeutic areas, while Trodelvy continues to be evaluated across additional cancer treatment settings.