Gilead’s supplemental Biologics Licence Application for Trodelvy (sacituzumab govitecan-hziy) for pre-treated hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer patients has been accepted by the US Food and Drug Administration (FDA) for priority review.
The application is supported by data from the registrational phase 2 TROPiCS-02 study, which met its primary endpoint of progression-free survival, as well as a key secondary endpoint of overall survival in patients who had received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.
In the study, Trodelvy demonstrated a 34% reduction in risk of disease progression or death and a 21% decrease in the risk of death over comparator chemotherapy.
Additionally, the safety profile for Trodelvy was consistent with prior studies and no new safety signals were observed, the company reported.
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%, Gilead reported.
As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy.
Commenting on the FDA’s decision, Bill Grossman, senior vice president, therapeutic area head, Gilead Oncology, said: “Trodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and today’s news marks our third supplemental application acceptance within the last two years.
“People with pre-treated HR+/HER2- metastatic breast cancer who have progressed on endocrine-based therapies and chemotherapy have limited treatment options, and we look forward to working with the FDA to potentially make Trodelvy available to patients who need it most.”
Trodelvy is approved in more than 35 countries for the treatment of 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.