FDA Approves Sacituzumab Govitecan for TNBC
On April 7, 2021, the FDA granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The full approval was based on results from the confirmatory Phase 3 ASCENT trial, which concluded in December 2020 and did not evaluate Trodelvy in combination with pembrolizumab.
The approval is based on results following the phase 3 ASCENT trial, a multicenter, open-label, randomized trial conducted in 529 patients with unresectable locally advanced or mTNBC who had relapsed following at least 2 prior chemotherapies if advancement occurred within 12 months.
Participants were randomized 1:1 to receive sacituzumab govitecan, 10 mg/kg as an intravenous infusion, on days 1 and 8 of a 21-day cycle (or physician’s choice of a single agent chemotherapy). The trial had a primary efficacy endpoint of progression-free survival (PFS) in patients without brain metastases at baseline. Additional efficacy endpoints included PFS for the full population both with and without brain metastases and overall survival (OS).1
Among all randomized patients (with or without brain metastases), median PFS for patients receiving sacituzumab govitecan was 4.8 months (95% CI = 4.1, 5.8) compared to 1.7 months (95% CI = 1.5, 2.5) in those receiving chemotherapy (hazard ratio = 0.43; 95% CI = 0.35, 0.54; p < 0.0001). Median OS was 11.8 months (95% CI = 10.5, 13.8) and 6.9 months (95% CI = 5.9, 7.6), respectively (hazard ratio = 0.51; 95% CI: 0.41, 0.62; p < 0.0001).
The most common (>25%) adverse reactions associated with sacituzumab govitecan include nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite, and abdominal pain. –Alexis Hyams
Source: US Food and Drug Administration. FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-sacituzumab-govitecan-triple-negative-breast-cancer?utm_medium=email&utm_source=govdelivery Accessed April 9, 2021.
