Policy & Regulation
Everest receives FDA approval for Trodelvy for the treatment of metastatic triple negative breast cancer
9 April 2021 -

Biopharmaceutical company Everest Medicines (HKEX 1952.HK) reported on Thursday the receipt of the the US Food and Drug Administration's (FDA) full approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The company added that the US FDA approval was awarded to its licensing partner Gilead Sciences Inc (Nasdaq:GILD). Everest Medicines is granted the exclusive rights to develop, register and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea and certain Southeast Asian countries.

Triple-Negative Breast Cancer (TNBC) is a highly aggressive disease and accounts for 15-20% of all breast cancer types worldwide. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy.

According to the company, Trodelvy (sacituzumab govitecan-hziy) is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers.

Based on the data from the Phase 3 ASCENT study, Trodelvy demonstrated statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy. Trodelvy extended median overall survival to 11.8 months over 6.9 months, a 49% reduction in the risk of death.

Currently, Everest Medicines is conducting a Phase 2b pivotal trial of sacituzumab govitecan-hziy for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease in China as well as initiated the submission of a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan-hziy for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease.

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