The first-in-class Trop-2-directed antibody-drug conjugate was approved for use on TNBC patients who have received at least two systemic therapies including one or more for advanced disease.
The EC approval is based on the positive results from the Phase III ASCENT study.
An assessment of the study data showed that Trodelvy lowered fatality risk by 49% and improved median overall survival to 11.8 months with physician’s choice of chemotherapy.
The global ASCENT study included more than 500 patients across 230 study locations.
TNBC is the one of the most aggressive types of breast cancer with a five-year survival rate of 12%. It is more frequently diagnosed in younger and premenopausal women.
Gilead Sciences chief medical officer Merdad Parsey said: “At Gilead, we push boundaries to deliver transformative science and novel treatment options that address urgent medical needs.
“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.”
Centre Eugène Marquis Department of Medical Oncology, Breast Cancer Group, senior medical oncologist head Dr Véronique Diéras said: “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.
“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.”
Trodelvy is already approved in Australia, the US, Canada, the UK and Switzerland.