Gilead Sciences has achieved a major milestone in breast cancer treatment as Trodelvy® (sacituzumab govitecan-hziy) received approvals from both the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for use as a first-line therapy in metastatic triple-negative breast cancer (mTNBC). The dual regulatory decisions significantly expand access to the antibody-drug conjugate (ADC), providing new treatment options for patients with one of the most aggressive forms of breast cancer.
In the United States, the FDA approved Trodelvy for adults with unresectable locally advanced or metastatic TNBC in two settings. It can now be used as monotherapy for patients who are not eligible for PD-1/PD-L1 inhibitor-based therapy, and in combination with pembrolizumab (Keytruda) for patients whose tumors are PD-L1 positive (Combined Positive Score ≥10), as determined by an FDA-authorized test. The approval makes Trodelvy the only approved antibody-drug conjugate (ADC) available as a first-line treatment across all PD-L1 status groups in metastatic TNBC.
Meanwhile, the European Commission granted marketing authorization for Trodelvy monotherapy as a first-line treatment for adults with unresectable or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1/PD-L1 inhibitors. The approval applies across all 27 European Union member states, as well as Norway, Iceland, and Liechtenstein, making Trodelvy the first ADC approved in Europe for this patient population.
Both regulatory approvals are supported by results from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 clinical trials. In ASCENT-03, Trodelvy monotherapy reduced the risk of disease progression or death by 38% compared with standard chemotherapy in patients ineligible for PD-1/PD-L1 inhibitors. In ASCENT-04, the combination of Trodelvy and pembrolizumab reduced the risk of progression or death by 35% compared with pembrolizumab plus chemotherapy in patients with PD-L1-positive disease.
Metastatic triple-negative breast cancer accounts for approximately 15% of all breast cancers and is associated with an aggressive disease course and limited treatment options. Many patients never receive second-line therapy because of rapid disease progression, making effective first-line treatment especially important. The latest approvals position Trodelvy earlier in the treatment pathway, where it has the potential to improve outcomes for a broader group of patients.
According to Gilead, more than 75,000 patients worldwide have already been treated with Trodelvy across its approved indications. With these latest approvals in both the United States and Europe, the company expects the therapy to become a new backbone treatment option for metastatic triple-negative breast cancer, further strengthening its oncology portfolio.
