FDA approved Trodelvy for HR-positive, HER2-negative breast cancer
The approval, dated February 3, 2023, covers unresectable locally advanced or metastatic disease.
The FDA approved sacituzumab govitecan-hziy, sold as Trodelvy by Gilead Sciences, Inc., for a new breast cancer indication on February 3, 2023. The approval covers unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, with HER2 status defined as IHC 0, IHC 1+ or IHC 2+/ISH-.1
The source document provided does not specify additional eligibility requirements, such as prior lines of endocrine therapy or chemotherapy, that patients must have received before qualifying for treatment under this approval. Readers seeking those details should consult the full FDA approval announcement or the drug's prescribing information for complete prescribing criteria.
No further milestones, trial results, or regulatory next steps are included in the available source material.
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