Overview
Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. Ribociclib was approved by the U.S. FDA in March, 2017 as Kisqali.
Indication
用于联合芳香酶抑制剂或氟维司群治疗激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的晚期或转移性乳腺癌成人患者。
Associated Conditions
- Advanced Breast Cancer
- Metastatic Breast Cancer
Research Report
A Comprehensive Scientific Monograph on Ribociclib (Kisqali®)
Executive Summary
Ribociclib, marketed under the brand name Kisqali®, is a highly selective, orally bioavailable small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).[1] Developed through a collaboration between Novartis and Astex Pharmaceuticals, Ribociclib has emerged as a transformative therapy and a cornerstone in the management of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, the most common subtype of the disease.[4] Its therapeutic action is rooted in its ability to interrupt a fundamental pathway that drives cancer cell proliferation.
The core mechanism of Ribociclib involves the targeted inhibition of the cyclin D-CDK4/6-retinoblastoma (Rb) protein pathway. By preventing the phosphorylation of the Rb protein, Ribociclib effectively halts the cell cycle in the G1 phase, inducing a state of cytostasis and thereby suppressing tumor growth.[2] This precise mechanism of action underpins its significant efficacy in HR+ breast cancer, where this pathway is frequently dysregulated.
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/03/25 | Phase 2 | Recruiting | SOLTI Breast Cancer Research Group | ||
2022/02/23 | Phase 1 | Active, not recruiting | |||
2022/02/14 | Phase 1 | Recruiting | |||
2022/01/31 | Phase 1 | Recruiting | |||
2022/01/26 | Phase 3 | Active, not recruiting | SOLTI Breast Cancer Research Group | ||
2021/12/17 | Phase 4 | Active, not recruiting | |||
2021/12/10 | N/A | Completed | |||
2021/09/09 | N/A | AVAILABLE | |||
2021/07/16 | Phase 3 | Active, not recruiting | |||
2021/04/28 | Phase 3 | Recruiting |
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