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Gilead’s Trodelvy approved by FDA for metastatic breast cancer

HR+/HER2- is the most common type of breast cancer, accounting for 70% of new cases


Gilead Science’s Trodelvy (sacituzumab govitecan-hziy) has been approved by the US Food and Administration (FDA) to treat metastatic breast cancer, the company announced.

The authorisation is specifically for adult patients with unresectable locally advanced or metastatic HR-positive, HER2-negative (HR+/HER2-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

HR+/HER2- breast cancer is the most common type of breast cancer, accounting for around 70% of all new cases, or nearly 400,000 diagnoses worldwide each year.

Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%.

As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy.

Gilead’s US application was supported by results from its phase 3 TROPiCS-02 study, in which Trodelvy demonstrated significant progression-free survival and overall survival (OS) benefits in this patient group.

In the study, Trodelvy showed a 34% reduction in risk of disease progression or death, as well as an OS benefit of 3.2 months over single-agent chemotherapy.

Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration.

“The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumour is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director at

Trodelvy is already approved in more than 40 countries to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic 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 at Gilead.

Trodelvy is also approved in the US under the accelerated approval pathway for pretreated adult patients with locally advanced or metastatic urothelial cancer.

Article by
Emily Kimber

6th February 2023

From: Regulatory



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