Trodelvy Receives CHMP Positive Opinion in Pre-Treated HR+/HER2- Metastatic Breast Cancer

Today, Gilead announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.

The positive recommendation is based on results from the Phase 3 TROPiCS-02 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful progression-free survival and overall survival benefit versus physician’s choice of chemotherapy.

Now that the CHMP has made its recommendation, the next step is for the European Commission (EC) to authorize this new indication for Trodelvy. We anticipate the final decision from the EC later this year.  

This press release will also be available at this link.