FOSTER CITY (dpa-AFX) - Gilead Sciences, Inc. (GILD) announced the FDA has accepted for priority review the supplemental Biologics License Application for Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The PDUFA target action date is currently set for February 2023.
The company noted that Trodelvy has not been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer.
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