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FDA Grants Regular Approval to Sacituzumab Govitecan-hziy for Pretreated Patients With Triple-Negative Breast Cancer


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On April 7, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

In April 2020, sacituzumab govitecan received accelerated approval for patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. The following trial was the confirmatory trial for the accelerated approval.

ASCENT Trial

Efficacy and safety were evaluated in a multicenter, open-label, randomized trial (ASCENT; ClinicalTrials.gov identifier NCT02574455) conducted in 529 patients with unresectable locally advanced or metastatic triple-negative breast cancer who had relapsed after at least two prior chemotherapies, one of which could be in the neoadjuvant or adjuvant setting, if disease progression occurred within 12 months. Patients were randomly assigned 1:1 to receive sacituzumab govitecan at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle (n = 627) or physician’s choice of single-agent chemotherapy (n = 262).

The primary efficacy endpoint was progression-free survival in patients without brain metastases at baseline as measured by a blinded independent centralized review assessed using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Additional efficacy endpoints included progression-free survival for the full population (with and without brain metastases) and overall survival.

Among all randomly assigned patients (with and without brain metastases), median progression-free survival for patients receiving sacituzumab govitecan was 4.8 months (95% confidence interval [CI] = 4.1–5.8 months) compared with 1.7 months (95% CI = 1.5–2.5 months) in those receiving chemotherapy (hazard ratio [HR] = 0.43, 95% CI = 0.35–0.54, P < .0001). Median overall survival was 11.8 months (95% CI = 10.5–13.8 months) and 6.9 months (95% CI = 5.9–7.6 months), respectively (HR = 0.51, 95% CI = 0.41–0.62, P < .0001).

The most commonly reported adverse reactions (incidence > 25%) in patients receiving sacituzumab govitecan were nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite, and abdominal pain.

The recommended sacituzumab govitecan dose is 10 mg/kg once weekly on days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity.

 


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