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With the latest EU approval, European patients with metastatic triple-negative breast cancer can now receive Gilead Sciences’ Trodlevy as part of their treatment
.
On November 24, 2021, Gilead Sciences announced the European Commission (EC) marketing authorization for Trodelvy (sacituzumad govitecan), an antibody-drug conjugate targeting Trop-2, and Trodelvy as a monotherapy It is used to treat adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more systemic treatments in the past
.
TNBC is the most aggressive type of breast cancer, accounting for about 15% of all breast cancers
.
It is more commonly diagnosed in young and premenopausal women, and more common in black and Hispanic women
The five-year survival rate for the
The EC decision was supported by the results of a global, open-label, randomized Phase III ASCENT study, which reached the primary and secondary endpoints of progression-free survival and overall survival
.
The study recruited more than 500 patients in 230 study sites and evaluated the efficacy of Trodelvy in patients with unresectable, locally advanced or metastatic TNBC who had received at least two previous treatments compared with the single-agent chemotherapy chosen by the doctor.
A total of 468 patients without brain metastases were randomly assigned to receive Trodelvy (235 patients) or chemotherapy (233 patients)
.
The median age was 54 years; all patients had used yews before
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