Augusti 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) alvi regularis FDA consecuta aegris cum nonsectabili localiter progresso vel metastatico carcinomate triplo-negativo (mTNBC) qui curationes systemicas systemicas duas vel plures accepit, quarum una saltem pro metastatica valetudine fuit.
Sacituzumab govitecan approbatione accelerato concessa est mense Aprili 2020 pro aegris cum mTNBC, qui ante saltem duas curationes metastaticae morbos habuerat. Iudicium confirmatorium celeri approbationis erat proximus gradus.
Efficacy and safety were assessed in 529 patients with unresectable locally advanced or mTNBC who had relapsed after at least two prior chemotherapies, one of which could have been in the neoadjuvant or adjuvant setting, if progression occurred within 12 months, in a multicenter, open-label, randomised trial (ASCENT; NCT02574455). On days 1 and 8 of a 21-day (n=267) cycle, patients were randomised (1:1) to receive sacituzumab govitecan, 10 mg/kg as an intravenous infusion, or a physician’s choice of single agent chemotherapy (n=262).
The primary effectiveness outcome was progression-free survival (PFS) in patients who did not have brain metastases at the start of the study, as determined by a blinded, independent, centralised review using RECIST 1.1 criteria. PFS for the entire cohort (with and without brain metastases) and overall survival were also included as effectiveness objectives (OS).
Aegroti accepto sacituzumab govitecan medianum PFS of 4.8 mensium (95 cento fiduciae intervallum: 4.1, 5.8) comparati sunt ad 1.7 menses (95 percent fiduciae intervalli: 1.5, 2.5) in iis chemotherapy receptis (HR 0.43; 95 percent fiduciae intervallum: 0.35; 0.54, p0.0001). Mediana OS erat 11.8 mensium (95 percent fiduciae intervallum: 10.5, 13.8) pro viris et 6.9 mensibus (95 percent fiduciae intervallum: 5.9, 7.6) foeminarum (HR 0.51; 95 percent fiduciae intervallum: 0.41, 0.62; p0.0001) .
Nausea, neutropenia, diarrhoea, lethargia, alopecia, anaemia, vomitus, constipatio, praeceps, appetitus decrescentes, et molestiae abdominis sunt praevalentes eventus latus (incidentiam >25%) in aegris sumendis sacituzumab govitecan.
Usque ad morbum progressum vel toxicitatem intolerabilem, suadeo sacituzumab dosis govitecani est 10 mg/kg semel hebdomadale in diebus 1 et 8 dierum 21 dierum cursus justo.
Reference: https://www.fda.gov/
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