The authorisation is specifically for adult patients with unresectable locally advanced or metastatic HR-positive, HER2-negative (HR+/HER2-) breast cancerHER2-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 cancerHR+/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.
As patients with HR+/HER2- metastatic breast cancerHR+/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 SurvivingBreastCancer.org.
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