Gilead's Trodelvy gets FDA priority review for expanded use in breast cancer subtype
Grandbrothers

The U.S. Food and Drug Administration (FDA) granted priority review to Gilead Sciences' (NASDAQ:GILD) application seeking expanded approval of Trodelvy to treat certain patients with a type of breast cancer.
The FDA accepted the company's supplemental Biologics License Application (sBLA) and is expected to make a decision by February, 2023. Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
The sBLA for Trodelvy (sacituzumab govitecan-hziy) is to treat adult patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC 0, IHC 1+ or IHC 2+/ISHâ) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
The filing was backed by data from a phase 3 trial called TROPiCS-02.
"Trodelvy has already changed the treatment landscape in second-line metastatic triple-negative breast cancer and pre-treated metastatic urothelial cancer, and todayâs news marks our third supplemental application acceptance within the last two years,â said Bill Grossman, senior vice president, Therapeutic Area head, Gilead Oncology.
Trodelvy is already approved in the U.S. to treat certain patients with a type of breast cancer and for certain adults with a type of urothelial cancer.
GILD +0.06% to $64.50 premarket Oct. 11.