Gilead Sciences' Trovelvy Scores FDA Approval For Advanced/Metastatic Breast Cancer Setting

The FDA has approved Gilead Sciences Inc's GILD Trodelvy (sacituzumab govitecan-hziy) for adult patients with advanced or metastatic breast cancer.
The approval covers unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
The approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase 3 TROPiCS-02 study.
Trodelvy is recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN).
In the TROPiCS-02 study, Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy.
Trodelvy also demonstrated a 34% reduction in disease progression or death risk.
Three times as many people treated with Trodelvy were progression-free at one year versus those treated with chemotherapy.
In 2022, Trodelvy generated sales of $680 million, 79% Y/Y, reflecting the continued adoption in metastatic triple-negative breast cancer in the U.S. and Europe.
Price Action: GILD shares are up 4.14% at $84.76 on the last check Friday.