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Gilead’s Trodelvy Gets Expanded Approval in Breast Cancer

February 8, 2023

Gilead’s $21 billion acquisition of Immunomedics and the cancer drug Trodelvy (sacituzumab govitecan-hziy) last year may soon pay off. This week, the FDA expanded approval of the drug to include the very common advanced HR-positive and HER2-negative (HR+/HER2- ) breast cancer.

Previously, Trodelvy was only approved for the treatment of the rare triple-negative breast cancer.

The expanded approval was based on statistically significant and clinically meaningful progression-free survival and overall survival data from a phase 3 study, said Gilead in a statement.

Three times as many people treated with Trodelvy were progression free at one year versus those treated with chemotherapy. Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration.

The safety profile for Trodelvy was consistent with prior studies, with no new safety signals identified in this patient population, Gilead said.

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