Gilead’s Trodelvy gains EC approval as new hope for metastatic breast cancer patients

In a significant advancement for cancer treatment, the European Commission (EC) has approved Gilead Sciences’ Trodelvy (sacituzumab govitecan) for the treatment of adult patients suffering from unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone endocrine-based therapy, and at least two more systemic therapies in the advanced phase.

This medication is now indicated for both pre-treated HR+/HER2- metastatic breast cancer and second-line metastatic triple-negative breast cancer in Europe.

The approval of Trodelvy follows the positive opinion of the Committee for Medicinal Products. It’s based on data from the Phase 3 TROPiCS-02 study, where the treatment showed a statistically significant and clinically meaningful overall survival (OS) benefit. Notably, Trodelvy demonstrated a survival benefit of 3.2 months compared to single-agent chemotherapy (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02).

“Trodelvy could change the outlook for women with pre-treated HR+/HER2- metastatic breast cancer by replacing the standard-of-care chemotherapy that has been their only option for decades,” said Bill Grossman, Senior Vice President, Therapeutic Area Head, Gilead Oncology.

Trodelvy is an innovative first-in-class Trop-2 directed antibody-drug conjugate. The Trop-2 cell surface antigen is found in high concentrations in multiple types of tumors, making this treatment a promising solution for more than 90% of breast and bladder cancers. Currently, Trodelvy is approved in over 40 countries for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer.