Following last year’s accelerated approval designation, the FDA granted regular approval to sacituzumab govitecan to treat patients with triple-negative breast cancer.
The FDA announced it has granted full approval to sacituzumab govitecan (Trodelvy) for the treatment of adults patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who received 2 or more prior systemic therapies, with at least 1 therapy for metastatic disease, according to an FDA press release.
The approval comes as a result of positive safety and efficacy data for 529 patients with unresectable locally advanced or mTNBC who relapsed after 2 or more prior systemic therapies, with at least 1 therapy for metastatic disease, reported from the multicenter, open-label, randomized ASCENT trial (NCT02574455).
This cohort of patients was randomized 1:1, with 267 patients assigned to receive 10 mg/kg as an intravenous infusion of sacituzumab govitecan on days 1 and 8 of a 21-day cycle and 262 patients assigned to receive physician’s choice of single agent chemotherapy.
Median progression-free survival (PFS) was recorded at 4.8 months (95% CI, 4.1-5.8) for patients in the sacituzumab govitecan group compared with 1.7 months (95% CI, 1.5-2.5) for patients in the chemotherapy group (HR, 0.43; 95% CI, 0.35-0.54; p < .0001).
More, median overall survival (OS) was 11.8 months (95% CI, 10.5-13.8) and 6.9 months (95% CI, 5.9-7.6) for patients in the sacituzumab govitecan group and chemotherapy group, respectively (HR, 0.51; 95% CI, 0.41-0.62; p < .0001).
The safety profile for patients in the sacituzumab govitecan group included common adverse events (defined as occurring in at least 25% of patients) such as nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite, and abdominal pain.
Overall, the recommended dose of sacituzumab govitecan is 10 mg/kg weekly on days 1 and 8 of a 21-day treatment cycle until disease progression or toxicity.
The primary end point of the ASCENT trial was PFS for patients without brain metastases measured by a blinded, independent, centralized review. Secondary end points included PFS for the entire patient population and OS.
Sacituzumab govitecan previously received accelerated approval for patients with mTNBC who received at least two prior therapies in April 2020, with the ASCENT trial serving as a confirmatory analysis for this accelerated approval. This regular approval came 6 weeks ahead of its scheduled goal date.
This regular review came through the Real-Time Oncology Review program, which streamlines the data submission prior to filing the clinical application in its entirety.
FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer. News release. FDA. Published April 7, 2021. Accessed April 7, 2021. 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