Sacituzumab govitecan is approved for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received 2 more prior systemic therapies.
In April 2021, the FDA granted approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received 2 more prior systemic therapies, including at least 1 for metastatic disease.
The drug was granted accelerated approval in April 2020 for patients with mTNBC who have received at least 2 prior therapies for metastatic disease. The approval was based on the phase 3 ASCENT trial, a multicenter, open-label, randomized trial conducted in 529 patients with unresectable locally advanced or mTNBC who had relapsed after at least 2 prior chemotherapies if progression occurred within 12 months.
The median PFS for patients receiving sacituzumab govitecan was 4.8 months compared with 1.7 months for patients receiving chemotherapy. The median OS was 11.8 months and 6.9 months, respectively. The recommended dose is 10 mg/kg once weekly on days 1 and 8 of 21-day treatment cycles, until disease progression or unacceptable toxicity.