February 21, 2024

US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer

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The US Food and Drug Administration (FDA) approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (

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Shah et al. (Wed,) studied this question.

synapsesocial.com/papers/68e78329b6db6435876f5edb https://doi.org/https://doi.org/10.1200/jco.23.02112

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1Elacestrant (RAD1901) exhibits anti-tumor activity in multiple ER+ breast cancer models resistant to CDK4/6 inhibitors2019 · 78 citations
2Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples2021 · 29 citations
3Abstract GS3-02: GS3-02 Camizestrant, a next generation oral SERD vs fulvestrant in post-menopausal women with advanced ER-positive HER2-negative breast cancer: Results of the randomized, multi-dose Phase 2 SERENA-2 trial2023 · 61 citations
4ESR1 ligand-binding domain mutations in hormone-resistant breast cancer2013 · 1,260 citations
5A sharper Bonferroni procedure for multiple tests of significance1988 · 4,742 citations

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