Trodelvy receives accelerated approval from the U.S. FDA for the treatment of metastatic urothelial cancer

Everest Medicines (Everest Medicines), a biopharmaceutical company focused on the development and commercialization of innovative drugs, is committed to meeting the unmet medical needs of Greater China and other Asian markets.
It announced today that the US Food and Drug Administration (FDA) has Accelerated approval of its partner Gilead Sciences (NASDAQ: GILD) Trodelvy® (sacituzumab govitecan-hziy) for the treatment of patients who have previously received platinum-containing chemotherapy and PD-1 or PD-L1 inhibitors Patients with locally advanced or metastatic urothelial carcinoma (mUC)
.

The accelerated approval is based on data obtained from the Phase 2 single-arm TROPHY clinical study, which involved 112 patients and found that the overall response rate of Trodelvy® was 27.
7%, and the median remission period was 7.
2 months
.
The full approval of this indication will depend on the clinical benefit verification results of confirmatory clinical studies

In the authorized introduction agreement signed with Gilead Sciences, Genting Shinya has the exclusive rights to develop, register and commercialize all cancer indications of sacituzumab govitecan-hziy in Greater China, South Korea and some Southeast Asian countries
.

Dr.
Kerui Bo, CEO of Genting Sunshine, said: “Metastatic urothelial cancer is a malignant disease, and the previous treatment options are very limited.
A long-awaited milestone for patients everywhere
.
Gilead Sciences has done a large number of encouraging data preparations in this important disease field, and formulated a comprehensive and continuous global registration strategy.

In December 2020, sacituzumab govitecan-hziy was approved by the Drug Evaluation Center of the National Medical Products Administration of China as a clinical trial application for a new drug for the treatment of metastatic urothelial cancer