Gilead Sciences Gets Priority Review for New Trodelvy Indication

The FDA has accepted Gilead Sciences’ supplemental Biologics License Application (sBLA) of Trodelvy (sacituzumab govitecan-hziy) for Priority Review in treating patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

The intravenous drug is already FDA-approved for 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. It is also under accelerated approval for locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either PD-1 or PD-L1 inhibitor.

The sBLA is supported by positive data from a phase 3 study, which demonstrated Trodelvy’s superior progression-free survival and overall survival versus comparator chemotherapy.

The FDA’s target action date for the supplemental BLA is February 2023.