Priority review for Trodelvy in pre-treated HR+/HER2- metastatic breast cancer

11 October 2022

The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) for Gilead Sciences’ (Nasdaq: GILD) Trodelvy (sacituzumab govitecan-hziy).

This sBLA is for the treatment of adults with unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

" ... our third supplemental application acceptance within the last two years"

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