US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting
Addition of adjuvant ribociclib to NSAI for adults with high-risk stage II and III hormone receptor-positive, HER2-negative EBC demonstrated a favorable benefit-risk profile with a statistically significant iDFS advantage. OS data remain immature.
Authors
- Ramesh Raghavachari
- Simon Redwood (ORCID: https://orcid.org/0000-0002-1937-063X)
- Yuching Yang (ORCID: https://orcid.org/0000-0001-8982-4863)
- Francis Green (ORCID: https://orcid.org/0000-0002-6786-5012)
- Tamy Kim
- Christy Osgood (ORCID: https://orcid.org/0000-0001-7450-9342)
- Haley Gittleman (ORCID: https://orcid.org/0000-0002-6976-8777)
- Corinne R. Leach (ORCID: https://orcid.org/0000-0002-5553-5980)
- Sherry Hou (ORCID: https://orcid.org/0009-0000-5883-5164)
- Shenghui Tang (ORCID: https://orcid.org/0000-0002-0437-665X)
- Huali Wu (ORCID: https://orcid.org/0000-0001-6767-5529)
- Nicole J. Gormley (ORCID: https://orcid.org/0000-0001-6379-5101)
- Tatiana M. Prowell (ORCID: https://orcid.org/0000-0002-8065-3399)
- Joyce Cheng (ORCID: https://orcid.org/0009-0006-0630-9844)
- Barbara K. Fuller
- Jennifer Gao (ORCID: https://orcid.org/0000-0003-1153-545X)
- Ilynn Bulatao (ORCID: https://orcid.org/0000-0002-4706-0372)
- William F. Pierce (ORCID: https://orcid.org/0000-0002-3411-7720)
- Richard Pazdur (ORCID: https://orcid.org/0000-0002-4771-9923)
- Stacie Woods
- Paul G. Kluetz (ORCID: https://orcid.org/0000-0002-9796-4791)
- Manuela Grimstein (ORCID: https://orcid.org/0000-0002-6430-3022)
- Laleh Amiri‐Kordestani (ORCID: https://orcid.org/0000-0002-0056-5437)
- George Chang (ORCID: https://orcid.org/0000-0002-3738-7646)
- Preeti Narayan (ORCID: https://orcid.org/0000-0003-0825-9087)
- Vishal Bhatnagar (ORCID: https://orcid.org/0000-0003-4650-0513)
- Tiffany K. Ricks
- Lyn R. Griffiths (ORCID: https://orcid.org/0000-0002-6774-5475)
- Rohit Kolhatkar (ORCID: https://orcid.org/0000-0002-8868-3357)
- Oladimeji Akinboro (ORCID: https://orcid.org/0000-0003-3847-1310)
- Chi‐Ming Tu (ORCID: https://orcid.org/0000-0003-1681-1652)
- Mallorie H. Fiero (ORCID: https://orcid.org/0000-0001-5536-116X)
- Mirat Shah (ORCID: https://orcid.org/0000-0003-0052-9978)
- Atiqur Rahman (ORCID: https://orcid.org/0000-0002-9001-5059)
- Mispa Ajua-Alemanji
- Qi Liu (ORCID: https://orcid.org/0000-0002-4053-4213)
- Hong Zhao (ORCID: https://orcid.org/0000-0003-4616-3123)
- Jingyu Yu (ORCID: https://orcid.org/0009-0006-6249-7907)
- Tingting Gao (ORCID: https://orcid.org/0000-0003-2765-4963)
Institutions
- United States Food and Drug Administration (US)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2025-08-11
- DOI
- https://doi.org/10.1200/jco-25-00167
- Citations
- 1
- Primary Topic
- Advanced Breast Cancer Therapies
- Type
- article
- Field-Weighted Citation Impact
- 1.52