EC Grants Marketing Authorization to Gilead’s Trodelvy

The European Commission (EC) has granted marketing authorization for Gilead’s Trodelvy (sacituzumab govitecan) to be used as a monotherapy to treat adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have already received two or more systemic therapies, with at least one of those for advanced disease. Gilead announced the positive outcome from the EC in a Nov. 23, 2021 press release.

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate, which has been specifically directed to the Trop-2 receptor—a protein that is overexpressed in numerous types of epithelial tumors. The commission’s decision was based upon Phase III trial data, demonstrating the efficacy of Trodelvy in reducing the risk of death and improving survival in TNBC patients.

“The metastatic stage of TNBC is particularly challenging to treat and until now we have urgently needed new treatment options for people in Europe living with this condition,” said Véronique Diéras, senior medical oncologist head, Breast Cancer Group, Department of Medical Oncology, Centre Eugène Marquis, Rennes, France, in a company press release. “Today’s approval including second-line metastatic TNBC is significant for the community as it’s another important step forward in helping women with this disease live longer.”

“At Gilead, we push boundaries to deliver transformative science and novel treatment options that address urgent medical needs,” said Merdad Parsey, chief medical officer, Gilead Sciences. “We understand how difficult metastatic TNBC is to treat and we’re proud that Trodelvy can now offer a second-line treatment option with the potential to bring longer life to people living with this aggressive disease.”

Source: Gilead