Gilead's Trodelvy (Sacituzumab Govitecan), the World’s First TROP-2 Targeting ADC, Approved in China for Metastatic Triple-Negative Breast Cancer

On June 10, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the marketing application for Sacituzumab Govitecan Injection, introduced by Everest Medicines, has been approved. According to previously disclosed information, the approved indication is for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies, with at least one of them being for metastatic disease.

Public information shows that Sacituzumab Govitecan is the world's first approved antibody-drug conjugate (ADC) targeting TROP-2, acquired by Gilead Sciences through the purchase of Immunomedics. Everest Medicines signed an exclusive licensing agreement with Gilead Sciences to obtain exclusive rights for the research, registration, and commercialization of all cancer indications of Sacituzumab Govitecan in Greater China, South Korea, and certain Southeast Asian countries.

Sacituzumab Govitecan is an ADC composed of an antibody targeting TROP-2 and a topoisomerase 1 inhibitor. TROP-2, fully known as human trophoblast cell surface antigen, is a protein overexpressed in many epithelial cancers (including metastatic TNBC and metastatic urothelial carcinoma), with high expression associated with low cancer survival rates and recurrence. Sacituzumab Govitecan can deliver the active metabolite of the chemotherapy drug irinotecan into cancer cells by binding to the TROP-2 protein. Additionally, the drug features a hydrolysable linker specifically designed to connect with the payload, ensuring its effective activity in Trop-2 expressing cells and the surrounding microenvironment.A therapy that significantly improves progression-free survival and overall survival in patients with triple-negative breast cancer compared to standard treatment.