FDA Approves Sacituzumab Govitecan-hziy for HR+/HER2- Metastatic Breast Cancer


Sacituzumab govitecan-hziy (Trodelvy) is a conjugated Trop-2-directed antibody and topoisomerase inhibitor previously approved for patients with triple-negative breast cancer.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences) for the treatment of adults 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 previously treated with endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting. The approval was based on findings from the phase 3 TROPiCS-02 study, which showed statistically significant and clinically meaningful rates of progression-free survival (PFS) and overall survival (OS).

“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, in a press release. “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-hziy is a conjugated Trop-2-directed antibody and topoisomerase inhibitor that was previously approved for the treatment of patients with triple-negative breast cancer administered 2 prior therapies at minimum for metastatic disease. Sacituzumab govitecan is included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, including a category 1 recommendation for use in adults with second-line metastatic triple-negative breast cancer, defined as at least 2 prior therapies with at least 1 line for metastatic disease.

“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, Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, US, and principal investigator of the TROPiCS-02 study, said in a press release. “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 3 months with a quality of life benefit for these women is exceptional.”

Data from TROPiCS-02 showed a statistically significant and clinically meaningful OS benefit of 3.2 months with sacituzumab govitecan-hziy compared with single-agent chemotherapy (treatment of physician’s choice; TPC) (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02).

Sacituzumab govitecan-hziy also showed a 34% decrease in the risk of disease progression or death (median PFS: 5.5 versus 4.0 months; HR: 0.66; 95% CI: 0.53-0.83; p=0.0003). Further, 3 times as many patients administered sacituzumab govitecan-hziy were progression-free at 1 year compared with patients administered chemotherapy (21% versus 7%).

TROPiCS-02 did not identify any new safety signals in this patient population. The most frequent serious adverse events (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). The most common grade 3-4 lab abnormalities (incidence ≥25%) were reduced neutrophils and leukocytes. No patients treated with sacituzumab govitecan-hziy experienced interstitial lung disease.

“We are pleased that Trodelvy could now provide new hope for people living with pre-treated HR+/HER2- metastatic breast cancer, building on the transformative role that Trodelvy is already playing for people with metastatic triple-negative breast cancer,” said Daniel O'Day, chairman and chief executive officer, Gilead Sciences, in a press release. “We thank the physicians, patients and their families who put their trust in the TROPiCS-02 study and helped make this milestone possible.”


U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer. Gilead. News release. 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.

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