The European Commission (EC) has granted marketing authorisation to Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) as a monotherapy for adult patients with unresectable or metastatic Triple-Negative Breast Cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.

The approval marks a significant milestone for breast cancer treatment in Europe, making Trodelvy the first Antibody-Drug Conjugate (ADC) approved for use in first-line metastatic TNBC across the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

TNBC is considered one of the most aggressive forms of breast cancer and is often associated with poorer outcomes due to limited treatment options. For many patients with metastatic TNBC, first-line therapy may be the only opportunity to effectively control disease progression, highlighting the importance of introducing innovative treatments earlier in the treatment journey.

The EC’s decision is based on results from the Phase 3 ASCENT-03 clinical trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with standard chemotherapy. The study showed that Trodelvy reduced the risk of disease progression or death by 38 percent in patients who were not eligible for PD-1/PD-L1 inhibitor therapy.

ASCENT-03 incorporated a patient-centered crossover design, allowing participants receiving chemotherapy to switch to Trodelvy after disease progression. The positive progression-free survival outcomes reinforced the benefits of introducing Trodelvy earlier in the treatment pathway for metastatic TNBC patients.

Commenting on the approval, Dr. Javier Cortes, Head of the International Breast Cancer Center in Madrid and Barcelona, said the authorisation offers renewed hope for patients facing metastatic TNBC, particularly younger women, by providing a treatment capable of delaying disease progression.

Mika Kakefuda Derynck, Senior Vice President of Clinical Development, Oncology at Gilead Sciences, described the approval as a major advancement in the treatment of first-line metastatic TNBC in Europe, noting that it addresses a significant unmet medical need for patients and healthcare providers.

Gilead is also seeking to expand Trodelvy’s use in Europe through a supplemental application submitted to the European Medicines Agency. The filing seeks approval of Trodelvy in combination with Keytruda (pembrolizumab) for patients with PD-L1-positive unresectable locally advanced or metastatic TNBC, based on findings from the Phase 3 ASCENT-04 study. The application is currently under review.

In the United States, the company has submitted supplemental applications to the US Food and Drug Administration seeking approval of Trodelvy both as a standalone treatment for patients ineligible for PD-(L)1 inhibitor therapy and in combination with Keytruda or Keytruda Qlex for patients with PD-L1-positive metastatic TNBC.

If additional approvals are secured, Trodelvy could become a foundational first-line treatment option for metastatic TNBC patients across different PD-L1 status groups, further expanding access to innovative therapies for this challenging disease.