NEW YORK – The US Food and Drug Administration on Friday approved Gilead Sciences' Trop-2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan) for patients with previously treated, hormone receptor-positive, HER2-negative metastatic breast cancer.
The agency approved Trodelvy for patients who have received endocrine-based therapy and at least two additional systemic treatments in the metastatic setting. Patients must be HER2-negative as determined via immunohistochemistry scores of IHC 0, IHC 1+, or IHC 2+ with negative in situ hybridization.
The FDA reviewed results from the Phase III TROPiCS-02 study, in which patients on Trodelvy experienced an improvement in overall survival and progression-free survival compared to those on chemotherapies chosen by their physicians. In that trial, Trodelvy-treated patients lived for a median of 14.4 months, whereas chemo-treated patients lived for a median of 11.2 months. The median progression-free survival time was 5.5 months with Trodelvy versus 4.0 months with chemo. After one year on treatment, 21 percent of patients were without disease progression, whereas the same was true of just 7 percent of patents on chemotherapy.
In a post hoc analysis, TROPiCS-02 investigators found that patients with both HER2-low and IHC 0 benefited from Trodelvy.
Last year, AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) received FDA approval for previously treated, HER2-low advanced breast cancer patients. That approval advanced a new category, in which patients with a score of IHC 1+, or IHC 2+ and negative in situ hybridization results — a subset previously considered HER2-negative and ineligible for HER2-targeted therapy — were now considered HER2-low.
Trodelvy is already approved in the US for advanced triple-negative breast cancer patients following systemic therapy and for advanced urothelial cancer patients after platinum-containing chemo and a PD-1 or PD-L1 inhibitor. After this latest FDA approval, the National Comprehensive Cancer Network has also recommended Trodelvy as a Category 1 preferred treatment for HR-positive, HER2-negative breast cancer.
"We are pleased that Trodelvy could now provide new hope for people living with pre-treated HR-positive, HER2-negative metastatic breast cancer, building on the transformative role that Trodelvy is already playing for people with metastatic triple-negative breast cancer," Gilead CEO and Chairman Daniel O'Day said in a statement.
The European Medicines Agency has also validated a marketing authorization application for Trodelvy in this patient population.