FOSTER CITY, Calif., June 24, 2026
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy® (sacituzumab govitecan-hziy) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). The approval establishes Trodelvy as the only approved Trop-2-directed antibody-drug conjugate (ADC) for first-line treatment across all PD-L1 status, either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Keytruda® (pembrolizumab) or Keytruda Qlex™ for patients with PD-L1-positive tumors (CPS ≥10). The expanded indication strengthens Trodelvy’s position as a new backbone therapy for one of the most aggressive forms of breast cancer while building on its established role in second-line metastatic TNBC and previously treated HR+/HER2-negative metastatic breast cancer.
Phase 3 Trials Deliver Significant Progression-Free Survival Benefits
The FDA approval is supported by positive results from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 clinical trials, both of which demonstrated highly statistically significant improvements in progression-free survival (PFS). In ASCENT-03, Trodelvy monotherapy reduced the risk of disease progression or death by 38% compared with chemotherapy in patients who were ineligible for PD-L1 inhibitor therapy. In ASCENT-04, Trodelvy combined with Keytruda reduced the risk of progression or death by 35% compared with Keytruda plus chemotherapy in patients with PD-L1-positive metastatic TNBC. The studies also reported substantially longer median duration of response, reaching 12.2 months versus 7.2 months in ASCENT-03 and 16.5 months versus 9.2 months in ASCENT-04, highlighting the therapy’s ability to provide more durable clinical responses than conventional chemotherapy.
Approval Expands Treatment Options for Aggressive Breast Cancer
Triple-negative breast cancer (TNBC) accounts for approximately 15% of all breast cancer cases and is associated with an aggressive disease course, earlier recurrence, and significantly lower long-term survival than other breast cancer subtypes. More than 50% of patients with metastatic TNBC never receive treatment beyond first-line therapy, making the availability of effective initial treatment particularly important. With more than 75,000 patients treated across over 60 countries, Trodelvy has already established itself as a leading treatment in advanced breast cancer. The latest approval also aligns with updated National Comprehensive Cancer Network (NCCN) recommendations, which now recognize Trodelvy, with or without Keytruda, as a Category 1 preferred first-line treatment for metastatic TNBC across all PD-L1 status, reinforcing its growing role in clinical practice.
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Gilead Strengthens Leadership in Antibody-Drug Conjugate Innovation
The approval further expands Gilead Sciences’ oncology portfolio and reinforces its leadership in developing antibody-drug conjugates (ADCs) for difficult-to-treat cancers. Trodelvy is a first-in-class Trop-2-directed ADC that delivers the topoisomerase I inhibitor SN-38 directly to tumor cells while also generating a bystander effect within the tumor microenvironment. Beyond metastatic TNBC, the therapy remains approved in multiple countries for pre-treated HR+/HER2-negative metastatic breast cancer and continues to be evaluated across several ongoing Phase 3 clinical trials in breast, lung, and gynecologic cancers. With this FDA approval, Gilead Sciences further strengthens its commitment to advancing innovative targeted cancer therapies while providing patients with a new first-line treatment option capable of improving outcomes in one of the most challenging forms of metastatic breast cancer.
Source: Gilead Sciences, press release
