FDA Grants Regular Approval to Trodelvy for Certain Patients With Triple-Negative Breast Cancer

The Food and Drug Administration (FDA) on Wednesday granted a regular approval to Trodelvy (sacituzumab govitecan) to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Trodelvy was originally granted an accelerated approval by the FDA in April 2020 and, therefore, needed efficacy to be confirmed in further trials for a full approval by the agency. The FDA based its full approval on results from the multicenter ASCENT trial.

In the randomized, open-label trial, researchers evaluated the safety and efficacy of Trodelvy in 267 patients with unresectable locally advanced or mTNBC who had relapsed after at least two prior chemotherapies versus physician’s choice of a single-agent chemotherapy in 262 patients.

Among all patients, median progression-free survival (time from treatment assignment to disease progression or all-cause death) for patients who received Trodelvy was 4.8 months compared to 1.7 months in those who received chemotherapy. Moreover, treatment with Trodelvy was associated with a median overall survival (time from treatment assignment and all-cause death) of 11.8 months compared to 6.9 months for those who received chemotherapy.

Side effects that occurred in more than 25% of patients who received Trodelvy included, but were not limited to, nausea, fatigue, anemia, constipation, rash and decreased appetite.

The FDA recommends patients receive Trodelvy at a dose of 10 milligrams/kilogram once per week on days 1 and 8 of 21-day treatment cycles until disease has progressed or patients can no longer tolerate the toxicities.

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