FDA nod for Trodelvy in pre-treated HR+/HER2- metastatic breast cancer

Gilead Sciences’ (Nasdaq: GILD) shares closed up 3.8% at $84.50 on Friday, after the US biotech major revealed a new US regulatory approval for one of its core growth drivers in the cancer setting.

The news was that the US Food and Drug Administration (FDA) has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of 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+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

The approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase III TROPiCS-02 study. Trodelvy is now also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines).