FOSTER CITY, Calif.– Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients 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 who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The FDA grants priority review for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The Prescription Drug User Fee Act (PDUFA) target action date is currently set for February 2023.
“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,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “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.”
This sBLA is based on data from the registrational Phase 3 TROPiCS-02 study, which met its primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS) over comparator chemotherapy (treatment of physician’s choice (TPC) of chemotherapy). PFS data were presented at the 2022 ASCO Annual Meeting and published in the Journal of Clinical Oncology, and OS data were recently presented at ESMO Congress 2022. In the study, Trodelvy demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 versus 4 months; hazard ratio [HR]: 0.66; 95% CI: 0.53-0.83; p=0.0003) and a 21% decrease in the risk of death compared to TPC (median OS: 14.4 months vs. 11.2 months; HR=0.789; 95% CI: 0.646-0.964; p=0.02).
The safety profile for Trodelvy in TROPiCS-02 was consistent with prior studies, with no new safety concerns identified in this population.
Trodelvy has not been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer. Its safety and efficacy have not been established for this indication.
Sacituzumab govitecan-hziy is currently included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®). This includes a Category 1 recommendation for use in adult patients with second-line metastatic triple-negative breast cancer (defined as those who received at least two prior therapies, with at least one line for metastatic disease) and a Category 2A preferred recommendation based on PFS data from TROPiCS-02 for investigational use in HR+/HER2- advanced breast cancer after prior treatment including endocrine therapy, a CDK4/6 inhibitor and at least two lines of chemotherapy. It also has a Category 2A recommendation for use in locally advanced or metastatic bladder cancer after prior treatment with platinum and a checkpoint inhibitor.
