EMA validates Gilead's Trodelvy MAA for TN breast cancer

The European Medicines Agency has validated the Marketing Authorization Application (MAA) for Trodelvy (sacituzumab govitecan-hziy; SG) for the treatment of adult patients with unresectable locally-advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies, including at least one prior therapy for locally advanced or metastatic disease.

US biotech major Gilead Sciences’ (Nasdaq: GILD) MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation

SG is a first-in-class therapy targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors, such as TNBC, where high expression is associated with poor survival and relapse. Currently, in the European Union, there is no authorized standard treatment regimen with proven benefit in overall survival (OS) for patients with previously treated metastatic TNBC.