OBR Daily Commentary


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

(Gilead) Apr 7, 2021 - Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to TrodelvyĀ® (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. The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001).

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Debu Tripathy, MD (Posted: April 08, 2021)


These are dramatic results not seen previously in any randomized trial for triple negative breast cancer, and more impressively in later lines of therapy (nearly 50% reduction in deaths). This is a very good sign as the design of antibody-drug conjugates become more sophisticated and more antibody/antigen-payload combinations are developed to represent a greater diversity of antineoplastic agents and tumor-specific surface receptors. Toxicities can be notable depending on the payload and factors that influence the amount of free drug in the circulation. These issues that can hopefully be mitigated by further innovations in design.



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