FDA Approves Sacituzumab Govitecan in Pretreated Metastatic Breast Cancer


Sacituzumab govitecan significantly improved overall survival over the comparator chemotherapy in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative breast cancer who had received prior treatment.

The FDA approved sacituzumab govitecan (Trodelvy; Gilead Sciences) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer.1

Trodelvy logo with dozing information

The therapy is a Trop-2–directed antibody drug conjugate and it is approved in patients who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. Sacituzumab govitecan is also recommended as a preferred treatment for metastatic HR+/HER2– breast cancer by the National Comprehensive Cancer Network guidelines.2

The approval was based on the TROPiCS-02 study, a global, multicenter, open-label phase 3 study that randomized 543 patients 1:1 to either sacituzumab govitecan or physicians’ choice of chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine).

“Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. Nearly all people with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies,” Hope S. Rugo, MD, professor of medicine and director of the Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, as well as principal investigator of the TROPiCS-02 study, said in a statement. “This approval is significant for the breast cancer community. We have had limited options to offer patients after endocrine-based therapy and chemotherapy, and to see a clinically meaningful survival benefit of more than three months with a quality-of-life benefit for these women is exceptional.”

The latest data on TROPiCS-02 was presented at the San Antonio Breast Cancer Symposium, held in December 2022.

In the study, the median overall survival (OS) of sacituzumab govitecan was 14.4 months vs 11.2 months for TPC (HR = 0.79; 95% CI: 0.65-0.96; P = .02). The therapy also had a 34% reduction in risk of disease progression or death with a median PFS of 5.5 months vs 4.0 months for TPC (HR: 0.66; 95% CI: 0.53-0.83; P = .0003). At 1 year, 21% of patients treated with sacituzumab govitecan were progression free compared with 7% of patients treated with TPC.

According to the results of the study, safety was similar with prior studies. The most frequent (> 1%) serious adverse reactions were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain (2%), colitis (2%), neutropenic colitis (2%), colitis (2%), pneumonia (2%), and vomiting (2%).Grade 3 to 4 lab abnormalities with an incidence of ≥ 25% were reduced neutrophils and leukocytes.

There is a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea.

“The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, Executive Director, SurvivingBreastCancer.org. “We need to combat this terrible disease, and all options that potentially slow its progress and extend life for those living with metastatic breast cancer are welcomed.”

Sacituzumab govitecan is already approved in the United States for locally advance or metastatic urothelial cancer for patients who have perceived a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.


1. U.S. FDA approves Trodelvy® in pre-treated HR+/HER2- metastatic breast Cancer. News Release. Gilead Sciences. February 3, 2023. Accessed February 3, 2023. https://www.gilead.com/news-and-press/press-room/press-releases/2023/2/us-fda-approves-trodelvy-in-pretreated-hrher2-metastatic-breast-cancer

2. Sacituzumab govitecan-hziy (Trodelvy®) elevated to Category 1 preferred recommendation in second-line metastatic triple-negative breast cancer and added as a Category 2A preferred recommendation for HR+/HER2- metastatic breast cancer in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). News Release. Gilead Sciences. August 3, 2022. Accessed February 3, 2023. https://www.gilead.com/news-and-press/company-statements/sacituzumab-govitecan-hziy-trodelvy-elevated-to-category-1-preferred-recommendation-in-second-line-metastatic-triple-negative-breast-cancer

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