FOSTER CITY, Calif., May 25, 2026
Gilead Sciences announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Trodelvy® (sacituzumab govitecan-hziy) as a first-line monotherapy treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1 or PD-L1 inhibitor therapy. The recommendation marks a major regulatory milestone for expanding treatment options in one of the most aggressive forms of breast cancer and could pave the way for a formal European Commission approval later in 2026.
ASCENT-03 Trial Showed Strong Survival Benefit
The CHMP recommendation is based on results from the Phase 3 ASCENT-03 clinical trial, where Trodelvy demonstrated a 38% reduction in the risk of disease progression or death compared with standard chemotherapy in first-line metastatic TNBC patients who were not candidates for PD-(L)1 inhibitors. The study achieved a highly statistically significant and clinically meaningful progression-free survival (PFS) advantage, reinforcing Trodelvy’s growing role in earlier treatment settings for breast cancer patients with limited therapeutic options.
According to Dr. Javier Cortes, Head of the International Breast Cancer Center in Madrid and Barcelona, the positive opinion reflects the urgent need for more effective frontline therapies in metastatic TNBC, where many patients may only receive one effective line of treatment during the course of their disease. He emphasized that introducing stronger therapies earlier could significantly improve long-term outcomes for patients facing poor survival rates associated with TNBC.
Trodelvy Expands Position in Breast Cancer Treatment
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Trodelvy is a Trop-2-directed antibody-drug conjugate (ADC) designed to deliver the active chemotherapy payload SN-38 directly into cancer cells while also affecting the surrounding tumor microenvironment through a bystander effect. The therapy is currently approved in more than 60 countries for previously treated metastatic TNBC and in over 50 countries for certain patients with pre-treated HR-positive/HER2-negative metastatic breast cancer.
Gilead highlighted that more than 75,000 breast cancer patients have been treated with Trodelvy globally since 2020. The company also stated that Trodelvy remains the only Trop-2 ADC to demonstrate meaningful overall survival benefits in both metastatic TNBC and HR+/HER2-negative metastatic breast cancer. Additionally, it is currently the only ADC with four positive Phase 3 studies in HER2-negative metastatic breast cancer.
The company has also submitted supplemental regulatory applications in both Europe and the United States for Trodelvy combined with Keytruda® (pembrolizumab) in patients with PD-L1 positive metastatic TNBC, based on data from the ASCENT-04 trial. If approved, the combination strategy could position Trodelvy as a backbone treatment across broader first-line metastatic TNBC populations regardless of PD-L1 status.
Safety Profile and Future Oncology Expansion
The safety profile of Trodelvy remains consistent with previous studies. The therapy carries a boxed warning for severe neutropenia and diarrhea, which are among the most commonly reported adverse reactions. Other frequently observed side effects include nausea, fatigue, alopecia, vomiting, constipation, anemia, and decreased appetite. Gilead recommends careful patient monitoring, supportive care measures, and prophylactic management strategies, including the use of G-CSF in high-risk patients.
Beyond breast cancer, Trodelvy is being evaluated in multiple ongoing Phase 3 studies across several tumor types with high Trop-2 expression, including lung and gynecologic cancers. Gilead continues to expand its oncology pipeline through antibody-drug conjugates, cell therapies, and combination treatment strategies aimed at improving survival outcomes in hard-to-treat cancers.
With the CHMP positive opinion, Gilead strengthens its position in the rapidly growing ADC market while potentially bringing a much-needed first-line treatment option to patients with metastatic TNBC across Europe.
Source: Gilead Sciences press release
