Sacituzumab Govitecan-hziy Receives Regular FDA Approval for Triple-Negative Breast Cancer
Posted: Thursday, April 8, 2021
On April 7, the U.S. Food and Drug Administration (FDA) approved the use of the monoclonal antibody sacituzumab govitecan-hziy (Trodelvy) to treat patients with unresectable locally advanced or metastatic triple-negative breast cancer who had two or more prior systemic therapies. One of those therapies would have to be for metastatic disease. This agent had received accelerated approval in April 2020 for patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease.
The FDA approval is based on the results of the multicenter, open-label phase III ASCENT trial. The study enrolled 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. About 267 patients were randomly assigned to receive 10 mg/kg of sacituzumab govitecan as an intravenous infusion on days 1 and 8 of a 21-day cycle. Approximately 262 patients were given a physician’s choice of single-agent chemotherapy.
Among all patients with and without brain metastases, the median progression-free survival for patients receiving sacituzumab govitecan was 4.8 months compared with 1.7 months for those receiving chemotherapy (P < .0001). The median overall survival was 11.8 months with sacituzumab govitecan versus the 6.9 months with chemotherapy (P < .0001).
The most common adverse reactions in more than 25% of patients receiving sacituzumab govitecan included 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. For full prescribing information, visit accessdata.fda.gov.