FDA Approval to Trodelvy and Patients With Breast Cancer


Date: 28.04.2021

The Food and Drug Administration (FDA) 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.

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.

Based on: ThePharmaLetter

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