BRIEF—Gilead secures EU nod for Trodelvy

Gilead Sciences has secured European approval for Trodelvy (sacituzumab govitecan) as a monotherapy for certain people with metastatic breast cancer.

The approval covers people with hormone receptor (HR)-positive, HER2-negative cancer who have received endocrine-based therapy, and at least two additional systemic therapies.

The decision was made based on results from the Phase III TROPiCS-02 study, which showed an overall survival (OS) benefit of 3.2 months, versus the comparator arm.

Senior VP Bill Grossman said: “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,”

“We look forward to working with European authorities to ensure access for these patients who need new treatment options,” he added.