FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer

FDA

24 June 2026 - Today, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) for two indications in adults with triple negative breast cancer. 

The first indication, supported by ASCENT-03, is for sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic triple negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. 

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US , Registration