2023. helmikuuta: 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).
Potilaat jaettiin satunnaisesti (1:1) saamaan joko yksittäisen aineen kemoterapiaa (n = 271) tai sacituzumab govitecan-hziya, 10 mg/kg laskimonsisäisenä infuusiona päivinä 1 ja 8 21 päivän syklissä. Ennen satunnaistamista tutkija valitsi yhden aineen kemoterapia-ohjelman yhdestä seuraavista vaihtoehdoista: kapesitabiini (n=22), vinorelbiini (n=63), gemsitabiini (n=56) tai eribuliini (n=130). Aikaisempia kemoterapia-ohjelmia metastaattisten sairauksien (2 vs. 3-4), sisäelinten etäpesäkkeiden (Kyllä tai Ei) ja endokriinisen hoidon metastaattisissa olosuhteissa vähintään 6 kuukauden ajan käytettiin kaikki satunnaistuksen kerrostamiseen (kyllä tai ei). Potilaat saivat hoitoa ei-hyväksyttävien sivuvaikutusten ilmaantumiseen asti.
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).
Vähentynyt leukosyyttien määrä (88 %), vähentynyt neutrofiilien määrä (83 %), alentunut hemoglobiini (73 %), vähentynyt lymfosyyttien määrä (65 %), ripuli (62 %), väsymys (60 %), pahoinvointi (59 %), hiustenlähtö (48 %), kohonnut glukoosi (37 %), ummetus (34 %) ja alennettu albumiini (32 %) olivat yleisimmät haittatapahtumat (25 %) potilailla, joita hoidettiin sacituzumab govitecan-hziylla TROPiCS-02:ssa.
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.
Katso Trodelvyn täydelliset reseptitiedot
