Gilead Sciences has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its Trodelvy (sacituzumab govitecan) to treat breast cancer.
Trodelvy will be used as a monotherapy to treat unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (not containing high levels of the protein HER-2) breast cancer in patients who have previously received endocrine-based therapy and a minimum of two additional systemic therapies in the advanced setting.
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The European Commission’s final decision on the additional indication is expected later this year.
Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate designed with a proprietary hydrolyzable linker that is attached to SN-38, a topoisomerase I inhibitor payload.
Gilead oncology therapeutic area head and senior vice-president Bill Grossman stated: “When patients with HR+/HER2- metastatic breast cancer develop resistance to endocrine-based therapies, treatment options are limited.
“Trodelvy has the potential to change this outlook, and we aim to build on the demonstrated benefits in second-line metastatic triple-negative breast cancer.
“This positive recommendation from the CHMP marks another important step toward making a difference for patients with pre-treated HR+/HER2- metastatic breast cancer in Europe.”
The CHMP’s opinion was supported by the findings obtained from the Phase III TROPiCS-02 trial.
The open-label, multicentre, international Phase III trial was designed to assess Trodelvy against physicians’ choice of chemotherapy (eribulin, capecitabine, gemcitabine or vinorelbine) in 543 HR+/HER2- metastatic breast cancer patients who have previously received endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy for metastatic disease.
Trodelvy showed a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months compared with single-agent chemotherapy.
