Gilead gets Trodelvy FDA approval for pre-treated HR+/HER2- metastatic breast cancer
Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Trodelvy (sacituzumab govitecan-hziy) for pre-treated HR+/HER2- metastatic breast cancer.
The Trop-2 directed antibody-drug conjugate (ADC) is indicated for the treatment of adults having unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who were subjected to prior endocrine-based therapy and at least a couple of additional systemic therapies in the metastatic setting.
Daniel O’Day — Gilead Sciences Chairman and CEO, commenting on Trodelvy FDA approval, said: “We are pleased that Trodelvy could now provide new hope for people living with pre-treated HR+/HER2- metastatic breast cancer, building on the transformative role that Trodelvy is already playing for people with metastatic triple-negative breast cancer.
“We thank the physicians, patients and their families who put their trust in the TROPiCS-02 study and helped make this milestone possible.”
Trodelvy FDA approval was driven by the positive progression-free survival and overall survival data from the TROPiCS-02 phase 3 clinical trial. The late-stage trial randomized 1:1 to study Trodelvy in comparison to physicians’ choice of chemotherapy in 543 patients having HR+/HER2- metastatic breast cancer who received prior treatment with endocrine therapy, CDK4/6 inhibitor, as well as two to four lines of chemotherapy for metastatic disease.
In the TROPiCS-02 phase 3 clinical trial, Trodelvy delivered an overall survival benefit of 3.2 months over single-agent chemotherapy or treatment of physician’s choice as well as a 34% lowering in risk of disease progression or death.
Gilead Sciences said that the European Medicines Agency had also validated a marketing authorization application for Trodelvy to be used for the treatment of HR+/HER2- metastatic breast cancer.