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Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

Food and Drug Administration (FDA) has granted full approval to Trodelvy ® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. months (HR: 0.51; 95% CI: 0.41-0.62;

HR 52
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Trodelvy® for the Treatment of Metastatic Urothelial Cancer

The Pharma Data

The FDA’s accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint. Premedicate with a two or three drug combination regimen (e.g., TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells.