Gilead Sciences application for breast cancer therapy gets EMA validation
Foster City: Gilead Sciences has recently announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for sacituzumab govitecan-hziy (SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies, including at least one prior therapy for locally advanced or metastatic disease.
The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation.
SG is a first-in-class therapy targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors, such as TNBC, where high expression is associated with poor survival and relapse. Currently, in the European Union (EU), there is no authorized standard treatment regimen with proven benefit in overall survival (OS) for patients with previously treated metastatic TNBC.
"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," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "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."
SG (under the tradename Trodelvy) received accelerated approval by the U.S. Food and Drug Administration (FDA) to treat adult patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
In addition to the European Union, regulatory reviews of SG in metastatic TNBC are currently underway in the U.K., Canada, Switzerland and Australia, as well as in Singapore through our partner Everest Medicines. SG is also under review by the FDA for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting, and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
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