Feb 2023: The Food and Drug Administration (FDA) has approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for people with hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer that has spread to other parts of the body and can not be removed. These people have also had at least two other systemic therapies in a metastatic setting.
TROPiCS-02 (NCT03901339) was a multicenter, open label, randomized study that looked at how well a CDK 4/6 inhibitor, endocrine therapy, and a taxane worked in 543 women with HR-positive, HER2-negative breast cancer that had spread or could not be removed. The patients’ disease got worse after receiving any of these treatments. At least two previous chemotherapies were administered to patients with metastatic disease (one of which could be in the neoadjuvant or adjuvant setting if recurrence occurred within 12 months).
Patienterna tilldelades slumpmässigt (1:1) för att få antingen kemoterapi med ett läkemedel (n = 271) eller sacituzumab govitecan-hziy, 10 mg/kg som en intravenös infusion, dag 1 och 8 i en 21-dagars cykel. Före randomiseringen valde utredaren en kemoterapiregim med enstaka medel från ett av följande alternativ: capecitabin (n=22), vinorelbin (n=63), gemcitabin (n=56) eller eribulin (n=130). Tidigare kemoterapiregimer för metastaserande sjukdom (2 mot 3-4), viscerala metastaser (Ja eller Nej) och endokrin terapi i metastaserande miljö under minst 6 månader användes alla för att stratifiera randomisering (Ja eller Nej). Patienterna fick behandling fram till början av oacceptabla biverkningar.
Progression-free survival (PFS), as defined by a blinded independent central review in accordance with RECIST v1.1, served as the primary efficacy outcome measure. Overall survival was a crucial secondary efficacy outcome metric (OS). The median PFS for the sacituzumab govitecan-hziy arm was 5.5 months (95% CI: 4.2, 7.0) and for the single agent chemotherapy arm was 4 months (95% CI: 3.1, 4.4) (hazard ratio [HR] of 0.661 [95% CI: 0.529, 0.826]; p-value=0.0003). For those getting sacituzumab govitecan-hziy, the median OS was 14.4 months (95% CI: 13.0, 15.7), whereas for those receiving single agent chemotherapy, it was 11.2 months (95% CI: 10.1, 12.7) (HR of 0.789 [95% CI: 0.646, 0.964]; p-value=0.0200).
Minskat antal leukocyter (88%), minskat antal neutrofiler (83%), minskat hemoglobin (73%), minskat antal lymfocyter (65%), diarré (62%), trötthet (60%), illamående (59%), alopeci (48 %), ökad glukos (37 %), förstoppning (34 %) och minskat albumin (32 %) var de vanligaste biverkningarna (25 %) hos patienter som behandlades med sacituzumab govitecan-hziy i TROPiCS-02.
On Days 1 and 8 of a 21-day therapy cycle, 10 mg/kg of sacituzumab govitecan-hziy should be infused intravenously once a week until the disease gets worse or the side effects become too much to handle, whichever comes first.
Project Orbis, an initiative of the FDA Oncology Center of Excellence, was used to carry out this review. Using the infrastructure that Project Orbis provides, international partners can submit and review oncology medications simultaneously. FDA worked together on this review with the Therapeutic Goods Administration (TGA) of Australia, Health Canada, and Swissmedic. At the other regulatory organizations, the application reviews are still proceeding.
Se fullständig förskrivningsinformation för Trodelvy
