Sacituzumab govitecan receives FDA approval for triple-negative breast cancer

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August 2021: 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.

Until disease progression or intolerable toxicity, the recommended sacituzumab govitecan dose is 10 mg/kg once weekly on days 1 and 8 of 21-day therapy cycles.


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