EMA validates Gilead Sciences’ application for breast cancer therapy

The European Medicines Agency (EMA) has validated Gilead Sciences’ marketing authorization application (MAA) for sacituzumab govitecan-hziy (SG) to treat advanced breast cancer.

SG is an antibody and topoisomerase inhibitor conjugate that targets Trop-2 cell surface antigen, a protein frequently expressed in multiple types of epithelial tumours, including triple-negative breast cancer (TNBC).

It treats adult patients with unresectable locally advanced or metastatic TNBC who have previously received at least two therapies, and at least one prior therapy for locally advanced or metastatic disease.

The company noted that there is no authorised standard treatment with proven benefit in overall survival (OS) for patients with previously treated metastatic TNBC in European Union (EU).

Gilead Sciences chief medical officer Merdad Parsey said: “Metastatic triple-negative breast cancer is an aggressive and life-threatening cancer. Unfortunately, for many people with this cancer, there are not enough effective treatment options and their prognosis is extremely poor.

“The validation of our EU marketing application is an important step toward addressing the significant unmet medical need for people with metastatic triple-negative breast cancer.”

The company stated that its MAA for the therapy is currently under accelerated review by the EMA.

Additionally, regulatory reviews of Gilead Sciences’ SG in metastatic TNBC are now underway in regions including the UK, Canada, Switzerland, Australia and in Singapore.

The therapy is also under review by the US Food and Drug Administration (FDA) for full marketing approval, to treat adult patients with locally advanced or metastatic urothelial cancer.

It is for the patients who have received a platinum containing chemotherapy prior in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.