Tháng 2021 năm XNUMX: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) gained regular FDA clearance for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic treatments, at least one of which was for metastatic illness.
Sacituzumab govitecan was granted accelerated approval in April 2020 for patients with mTNBC who had previously had at least two treatments for metastatic illness. The confirmatory trial for the speedy approval was the next step.
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).
Patients receiving sacituzumab govitecan had a median PFS of 4.8 months (95 percent confidence interval: 4.1, 5.8) compared to 1.7 months (95 percent confidence interval: 1.5, 2.5) in those receiving chemotherapy (HR 0.43; 95 percent confidence interval: 0.35, 0.54; p0.0001). The median OS was 11.8 months (95 percent confidence interval: 10.5, 13.8) for men and 6.9 months (95 percent confidence interval: 5.9, 7.6) for women (HR 0.51; 95 percent confidence interval: 0.41, 0.62; p0.0001).
Nausea, neutropenia, diarrhoea, lethargy, alopecia, anaemia, vomiting, constipation, rash, decreased appetite, and abdominal discomfort are the most prevalent side events (incidence >25%) in patients taking sacituzumab govitecan.
Cho đến khi bệnh tiến triển hoặc độc tính không thể dung nạp, liều sacituzumab govitecan được khuyến nghị là 10 mg/kg mỗi tuần một lần vào ngày 1 và 8 của chu kỳ điều trị 21 ngày.
Tài liệu tham khảo : https://www.fda.gov/
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