# Ribociclib

Source: https://onco.cc/drugs/ribociclib/  
OnCo record `ribociclib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Ribociclib is the CDK4/6 inhibitor with the most consistent survival benefit, approved for a broad population of early breast cancer patients since 2024.

## Summary

Ribociclib is a CDK4-biased CDK4/6 inhibitor given for 21 days of a 28-day cycle with an aromatase inhibitor or fulvestrant, at 600 mg daily in advanced disease or 400 mg daily for 3 years in the adjuvant setting. Its survival data are the most consistent in the class: MONALEESA-2, -3 and -7 each showed an overall survival benefit in HR-positive, HER2-negative advanced breast cancer, and NATALEE extended it to stage II-III early disease, including node-negative tumours, with an invasive disease-free survival HR of 0.75 (4-year iDFS 88.5% versus 83.6%), leading to adjuvant approval in September 2024. Novartis markets it. Neutropenia is near-universal (94%), and QT and liver enzymes need monitoring. Whether the adjuvant benefit matures into a survival gain remains open. For a newcomer: the CDK4/6 pill with the broadest proven benefit in hormone-driven breast cancer.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Also known as: Ribociclib Succinate and Letrozole; Kisqali Femara Co-Pack
- Brand: Kisqali
- Modality: Small-molecule CDK4/6 inhibitor
- Mechanism: CDK4-biased CDK4/6 inhibitor.
- Approvals: US 2017: HR+/HER2- advanced breast cancer; US 2024: Adjuvant stage II-III HR+/HER2- breast cancer at high risk of recurrence
- Dosing: Oral; 600 mg once daily (advanced) or 400 mg once daily (adjuvant, 3 years) for 21 days then 7 off, with aromatase inhibitor or fulvestrant
- Toxicity (grade 3+): Neutrophils decreased 45%; ALT/AST increased (grade 3-4) 8%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Ribociclib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Ribociclib

## Connected records

- cancers: [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Invasive lobular carcinoma of the breast](https://onco.cc/cancers/invasive-lobular-carcinoma/), [Male breast cancer](https://onco.cc/cancers/male-breast-cancer/)
- technologies: [CDK4/6 inhibitors](https://onco.cc/technologies/cdk46-inhibitor/)
- targets: [CDK4/6](https://onco.cc/targets/cdk4-6/)
- companies: [Novartis](https://onco.cc/companies/novartis/), [Olema Pharmaceuticals](https://onco.cc/companies/olema-pharmaceuticals/), [SOLTI Cancer Research Group](https://onco.cc/companies/solti/)
- trials: [A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With ](https://onco.cc/trials/nct06188520/), [A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC](https://onco.cc/trials/nct07002177/), [A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer](https://onco.cc/trials/nct07405801/), [A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer](https://onco.cc/trials/nct07647328/), [A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer](https://onco.cc/trials/nct04802759/), [A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)](https://onco.cc/trials/nct06065748/), [A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer](https://onco.cc/trials/nct07054190/), [Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)](https://onco.cc/trials/nct04862663/), [First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct05768139/), [MONALEESA-2](https://onco.cc/trials/monaleesa-2/), [NATALEE](https://onco.cc/trials/natalee/), [Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer](https://onco.cc/trials/nct05563220/), [Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer](https://onco.cc/trials/nct07085767/), [Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)](https://onco.cc/trials/nct06757634/), [Phase IIIb Study of Ribociclib + ET in Early Breast Cancer](https://onco.cc/trials/nct05827081/), [Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation](https://onco.cc/trials/nct05358249/), [Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer](https://onco.cc/trials/nct06380751/), [Study of AVZO-021 in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct05867251/), [Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors](https://onco.cc/trials/nct06726148/), [Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma](https://onco.cc/trials/nct04417621/), [Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease](https://onco.cc/trials/nct06760637/), [TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)](https://onco.cc/trials/nct05573555/)
- ideas: [CDK4-selective inhibitors as the new first-line backbone](https://onco.cc/ideas/idea-cdk4-selective-first-line/), [Payers fund trials of cheaper, shorter or lower-dose versions of expensive treatments](https://onco.cc/ideas/idea-fund-payer-funded-pragmatic-trials/)
- pathways: [Breast cancer (KEGG map)](https://onco.cc/pathways/breast-cancer-signalling/), [Oestrogen receptor signalling](https://onco.cc/pathways/er-signaling/), [p53 / RB / cell-cycle checkpoint](https://onco.cc/pathways/p53-cell-cycle/), [The cell-cycle engine (cyclins & CDKs)](https://onco.cc/pathways/cell-cycle-engine-cdks/)
- pairings: [CDK4/6 inhibitor + endocrine therapy](https://onco.cc/pairings/cdk46-plus-endocrine/)
- people: [Debu Tripathy](https://onco.cc/people/debu-tripathy/), [Dennis J. Slamon](https://onco.cc/people/dennis-slamon/), [Gabriel N. Hortobagyi](https://onco.cc/people/gabriel-hortobagyi/), [Seock-Ah Im](https://onco.cc/people/im-seock-ah/)
- key papers: [NATALEE: three years of ribociclib after surgery in a broad population of hormone-receptor-positive early breast cancer](https://onco.cc/key-papers/paper-natalee-nejm-2024/)
- terms: [Cell cycle](https://onco.cc/terms/cell-cycle/), [QT prolongation](https://onco.cc/terms/qt-prolongation/)
- biomarkers: [ER status (oestrogen receptor by IHC)](https://onco.cc/biomarkers/er-status/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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JSON: https://onco.cc/api/v1/entities/ribociclib.json