– Trodelvy is a New Backbone Therapy and the Only Approved ADC in First-Line mTNBC Across PD-L1 Status –
– Approval Builds on Trodelvy’s Leadership in Second-Line mTNBC and Pre-Treated HR+/HER2- Metastatic Breast Cancer with More than 75,000 Patients Treated Globally –
June 24, 2026--FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy® (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). Trodelvy is now approved in first-line mTNBC 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™ (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
“For people living with mTNBC, the first treatment choice can be pivotal, as many patients may not have the opportunity to receive subsequent therapies,” said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and a principal investigator of the ASCENT-03 and ASCENT-04 studies. “This approval is heartening news for patients and the clinical community, and I believe offers a practice-changing first-line treatment option for all patients across PD-L1 status.”
The FDA approval is based on highly statistically significant and clinically meaningful progression-free survival (PFS) data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials, where Trodelvy-based regimens significantly reduced the risk of disease progression or death in first-line mTNBC—by 38% as monotherapy versus chemotherapy in PD-L1 ineligible disease in ASCENT-03 and by 35% in combination with Keytruda versus Keytruda plus chemotherapy in PD-L1+ disease in ASCENT-04.
Across ASCENT-03 and ASCENT-04, Trodelvy-based regimens delivered markedly more durable responses, with median duration of response of 12.2 versus 7.2 months with chemotherapy in ASCENT-03 and 16.5 versus 9.2 months for Trodelvy plus Keytruda versus Keytruda plus chemotherapy in ASCENT-04 by blinded independent central review.
“For patients with metastatic TNBC, a new first-line treatment option offers optimism to a community with historically few choices,” said Ricki Fairley, Co-Founder and CEO of TOUCH, The Black Breast Cancer Alliance. “TNBC disproportionately affects younger women - many in the prime of their lives - and often leads to poorer outcomes. Because so many patients may never receive subsequent lines of therapy, the ability to start with a promising option like Trodelvy with or without Keytruda is critical. We have sought additional alternatives to chemotherapy-containing regimens in the first-line metastatic setting since TNBC was classified as a disease more than 20 years ago. As such, this approval represents meaningful progress for the families impacted by this disease.”
“The FDA’s approval of Trodelvy provides a new standard of care for the most aggressive form of breast cancer,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “For more than twenty years, patients with mTNBC have had limited choices in first-line treatment. Building on its impact in second-line mTNBC, Trodelvy now offers patients a powerful new backbone therapy option in the first-line setting.”
Based on the ASCENT-03 and ASCENT-04 positive study results, the National Comprehensive Cancer Network® (NCCN®) recommends Trodelvy with or without Keytruda as a category 1 preferred first-line treatment option for people with mTNBC across PD-L1 status in the NCCN Guidelines®i. Trodelvy also has a category 1 recommendation in second-line mTNBC and in pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer (mBC).
Healthcare professionals have well-established experience with Trodelvy, with more than 75,000 breast cancer patients treated across more than 60 countries over the past six years. It remains the only Trop-2-directed ADC to demonstrate meaningful overall survival benefits in both second-line or later metastatic TNBC and pre-treated HR+/HER2- mBC. It is also the only ADC with four positive Phase 3 trials in HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) mBC.
Please see below for the U.S. Indication and Important Safety Information for Trodelvy, including Boxed Warning.
KEYTRUDA® and KEYTRUDA QLEX™ are trademark(s) of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Triple-Negative Breast Cancer
TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.
First-line metastatic TNBC has seen limited new approvals in recent years and additional options are urgently needed. Over 50% of patients do not receive treatment beyond first-line, reinforcing the urgent need for new options to help improve patient outcomes. Breast cancers expressing PD-L1 are overall more aggressive and associated with reduced survival time.
About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.
Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Global regulatory submissions for the approval of Trodelvy based on ASCENT-03 and ASCENT-04 are underway.
Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.
About Gilead and Kite Oncology
Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
i Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer Version 4.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed June 16, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.