Gilead Announces NMPA Approval of Trodelvy (Sacituzumab Govitecan) for HR+/HER2- Metastatic Breast Cancer in China

On March 21, 2025, Gilead Sciences announced that Trodelvy (generic name: sacituzumab govitecan) had been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have previously received endocrine therapy and at least two other systemic therapies in the metastatic disease setting. Trodelvy is the world’s first approved antibody-drug conjugate (ADC) targeting Trop-2. It was already approved in China in 2022 for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies (at least one of which was for metastatic disease).
Currently, breast cancer remains one of the malignant tumors with the highest incidence and mortality rates among women globally. Data on the disease burden of malignant tumors in China released by the National Cancer Center showed that in 2022, the incidence rate of breast cancer among Chinese women was 51.17 cases per 100,000 people, and the mortality rate was 10.86 deaths per 100,000 people [1]. HR+/HER2- breast cancer is one of the most common subtypes of breast cancer, accounting for approximately 70% of all breast cancer cases [2]. For a long time, endocrine therapy (ET) has been the primary treatment for these patients. However, if patients develop endocrine resistance or their disease progresses to an advanced stage, treatment options remain very limited.
Professor Binghe Xu, academician of the Chinese Academy of Engineering, director of the National Clinical Research Center for New Anti-tumor Drugs, and principal investigator of the Trodelvy China registration study, stated: "For patients with HR+/HER2- advanced breast cancer who have progressed on endocrine therapy, there was no standard later-line treatment regimen in the past. Overcoming endocrine resistance and further improving patient outcomes has been an enormous challenge. In a multicenter clinical study in Asia, including mainland China, Trodelvy not only demonstrated consistent treatment effects with studies from other regions globally, but its safety is also commendable. The approval of Trodelvy's HR+ indication this time will provide these patients with a new treatment option, helping them prolong their lives while achieving a higher quality of survival."
Jin Fangqian, Global Vice President of Gilead Sciences and General Manager of China, stated: "Gilead Sciences is known for its courage to innovate and set high standards. We are committed to revolutionizing drug development in the field of oncology. In the past few years, we have obtained approvals for eight oncology indications worldwide. At the same time, we actively collaborate with governments, health institutions, academic experts, industry partners, and patients to transform cancer treatment methods. The recent approval of the HR+ indication in China further expands Gilead China's capabilities in the treatment of metastatic breast cancer. Building on this momentum, we will continue to strive in the fields of breast cancer and broader oncology to help more patients achieve the impossible."
[1] Han B, Zheng R, Zeng H, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024;4(1):page. DOI: 10.1016/j.jncc.2024.01.006
[2] Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014 Apr 28;106(5):dju055.