Gilead Trodelvy receives positive opinion from EU CHMP for treatment of breast cancer

CompilationFan Dongdong

A few days ago, Gilead ADC drug Trodelvy has received positive opinions from the European Medicines Agency (EMA) Committee on Medicinal Products for Human Use (CHMP) for monotherapy in adult patients with unresectable or metastatic triple-negative breast cancer (TNBC)

This time Trodelvy received positive opinions from the European Union, mainly based on the positive results of the Phase 3 ASCENT trial

Just 5 months ago, the FDA approved Gilead Trodelvy for the same indication in April, and the drug is currently on the market in the UK, Australia, Switzerland and Canada

Trodelvy was originally developed by Immunomedics.

Trodelvy is a new and pioneering antibody-conjugated drug (ADC) targeting Trop-2.

In addition, Gilead’s development plan for Trodelvy also includes the exploration of multiple other solid tumor indications, such as other types of metastatic triple-negative breast cancer and metastatic urothelial cancer, hormone receptor positive/human epidermal growth 2- negative factor receptor (HR + / HER2-) metastatic breast cancer and metastatic non-small cell lung cancer

In terms of competitors, in March 2019, the U.

Reference source: Gilead's Trodelvy set for EU approval in breast cancer