The European Commission gives the green light to sacituzumab govitecan, under the trade name Trodelvy, to combat a tumor that represents 15% of all breast tumors
The European Commission has authorized the marketing of a drug indicated for the treatment of adult patients with metastatic triple negative breast cancer (TNTC) who have received two or more previous systemic treatments, at least one of them for advanced disease. The drug sacituzumab govitecan will be marketed under the name Trodelvy by the US biotech company Gilead Sciences.
“The metastatic stage of CMTN is especially difficult to treat and we urgently needed new treatment options for people with this disease in Europe,” said Dr. Véronique Diéras, lead medical oncologist in the Breast Cancer Group of the Department of Medical Oncology. from the Eugène Marquis Center in Rennes (France). “Today’s approval, which includes second-line metastatic CMTN, is significant for the entire medical community as it is an important step in helping women with this disease live longer,” he concludes.
CMTN is the most aggressive type of breast cancer, accounting for approximately 15% of all breast cancers. It is most often diagnosed in young and premenopausal women and is more common in black and Hispanic women. The 5-year survival rate for this subtype of breast cancer is 12%, compared to 28% for other types of breast cancer, and these poor outcomes are often accompanied by a significant decrease in quality of life.
Less risk of death
“We understand how difficult it is to treat metastatic CMTN and we are proud to now offer a second-line treatment option with the potential to extend the lives of people living with this aggressive disease,” said Merdad Parsey, Medical Director of Gilead Sciences.
The European Commission’s decision is supported by the results of the phase 3 ASCENT study, which shows that the molecule reduced the risk of death by 49% and improved the median overall survival to 11.8 months versus 6, 9 months with chemotherapy chosen by the doctor.
In addition to this authorization for the EU market, the treatment is approved in Australia, Canada, Great Britain, Switzerland and the United States.