FDA approves Trodelvy for first-line treatment of metastatic triple-negative breast cancer

The U.S. Food and Drug Administration (FDA) has approved Trodelvy® (sacituzumab govitecan) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). 

The approval expands Trodelvy’s indication to earlier lines of therapy and includes use as a monotherapy in patients who are not candidates for PD-(L)1 inhibitor-based treatment. In addition, Trodelvy is approved in combination with pembrolizumab, with or without berahyaluronidase alfa-mph, for patients whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-authorized diagnostic test.

This regulatory decision is supported by Phase 3 clinical data demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS), both in monotherapy and in combination with the PD-(L)1 inhibitor pembrolizumab. The results confirm the clinical benefit of Trodelvy across different PD-L1 expression subgroups and support its role as a backbone therapy in the management of mTNBC.

The approval represents a significant advancement in the therapeutic landscape of triple-negative breast cancer, a highly aggressive disease with limited treatment options. First-line treatment is considered critical in influencing disease progression and patient outcomes in this setting.

This milestone also reflects the broader evolution of Gilead’s oncology portfolio, which encompasses antibody-drug conjugates, immunotherapies, tumor-targeting therapies, and combination strategies aimed at addressing unmet medical needs in oncology.