# Abemaciclib

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

## TL;DR

Abemaciclib was the first CDK4/6 inhibitor approved after surgery for high-risk hormone-positive breast cancer.

## Summary

Abemaciclib is a CDK4-biased CDK4/6 inhibitor potent enough for continuous dosing, at 150 mg twice daily with endocrine therapy or 200 mg twice daily alone. MONARCH 2 and 3 established it in HR-positive, HER2-negative advanced breast cancer (overall survival benefit in MONARCH 2), and monarchE made it the first CDK4/6 inhibitor approved after surgery for high-risk node-positive disease (2021, label broadened 2023): 2 years of treatment gave an invasive disease-free survival HR of 0.68 at 5 years (83.6% versus 76.0%), with a favourable but not yet significant overall survival trend. Eli Lilly markets it. Diarrhoea is the defining toxicity (85%, 8% grade 3 or higher). Whether the recurrence benefit becomes a survival benefit is open. For a newcomer: the CDK4/6 pill that first proved it could stop early breast cancer coming back.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Verzenio
- Modality: Small-molecule CDK4/6 inhibitor
- Mechanism: CDK4-biased inhibitor with continuous dosing.
- Approvals: US 2017: HR+/HER2- advanced breast cancer; US 2021: Adjuvant high-risk node-positive HR+/HER2- early breast cancer
- Dosing: Oral, continuous; 150 mg twice daily with endocrine therapy (2 years adjuvant); 200 mg twice daily as monotherapy
- Toxicity (grade 3+): Diarrhoea 8%; Neutropenia 19%; Infections 3%; Venous thromboembolism 2%; Interstitial lung disease 0.5%

## Sources

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

## Connected records

- cancers: [Advanced or recurrent endometrial cancer](https://onco.cc/cancers/advanced-recurrent-endometrial-cancer/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Endometrial cancer with no specific molecular profile](https://onco.cc/cancers/endometrial-nsmp/), [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/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/), [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: [Eli Lilly (incl. Loxo)](https://onco.cc/companies/eli-lilly/)
- 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 Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer](https://onco.cc/trials/nct05999994/), [A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC](https://onco.cc/trials/nct07002177/), [A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy](https://onco.cc/trials/nct06413706/), [A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer](https://onco.cc/trials/nct04802759/), [A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer](https://onco.cc/trials/nct02107703/), [A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer](https://onco.cc/trials/nct02763566/), [A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer](https://onco.cc/trials/nct02152631/), [A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer](https://onco.cc/trials/nct02747004/), [A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)](https://onco.cc/trials/nct05288166/), [A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer](https://onco.cc/trials/nct03706365/), [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 Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer](https://onco.cc/trials/nct07100106/), [Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer](https://onco.cc/trials/nct07441369/), [Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer](https://onco.cc/trials/nct06365788/), [CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma](https://onco.cc/trials/nct05440786/), [Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)](https://onco.cc/trials/nct04862663/), [EMBER-3](https://onco.cc/trials/ember-3/), [Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation](https://onco.cc/trials/nct05696626/), [Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies](https://onco.cc/trials/nct07340541/), [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/), [MONARCH 3](https://onco.cc/trials/monarch-3/), [monarchE](https://onco.cc/trials/monarche/), [Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer](https://onco.cc/trials/nct05735080/), [Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer](https://onco.cc/trials/nct05573126/), [postMONARCH](https://onco.cc/trials/postmonarch/), [Probiotics for Abemaciclib-Induced Abdominal Discomfort.](https://onco.cc/trials/nct07605728/), [Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss](https://onco.cc/trials/nct06810544/), [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 Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer](https://onco.cc/trials/nct05386108/), [Study of AVZO-021 in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct05867251/), [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 A)](https://onco.cc/trials/nct05548127/), [Using Tumor Models to Determine Treatments](https://onco.cc/trials/nct06813079/), [ZEN-3694 with abemaciclib in NUT carcinoma, breast cancer and other solid tumours (NCI phase 1)](https://onco.cc/trials/zen-3694-abemaciclib-nut/)
- pairings: [CDK4/6 inhibitor + endocrine therapy](https://onco.cc/pairings/cdk46-plus-endocrine/), [Oral SERD + CDK4/6 inhibitor after ESR1 emergence](https://onco.cc/pairings/oral-serd-plus-cdk46-after-esr1/)
- ideas: [CDK4-selective inhibitors as the new first-line backbone](https://onco.cc/ideas/idea-cdk4-selective-first-line/), [Fund trials that test shorter courses of the most expensive adjuvant drugs](https://onco.cc/ideas/idea-cost-shorter-course-trials/), [GLP-1 receptor agonists as adjuvant weight-loss therapy in HR-positive breast cancer](https://onco.cc/ideas/idea-nl-glp1-adjuvant-hr-breast/), [Randomised lower-dose trials for approved drugs with quality of life as the primary endpoint](https://onco.cc/ideas/idea-moon-post-approval-dose-deescalation/), [Start low and step up: individualised titration of oral cancer drugs, randomised](https://onco.cc/ideas/idea-tr1-start-low-titrate-up-oral-agents/)
- 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/)
- people: [Komal Jhaveri](https://onco.cc/people/komal-jhaveri/), [Matthew P. Goetz](https://onco.cc/people/matthew-goetz/), [Miguel Martín](https://onco.cc/people/miguel-martin/), [Stephen Johnston](https://onco.cc/people/stephen-johnston/)
- bottlenecks: [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)
- key papers: [monarchE: two years of abemaciclib after surgery in high-risk, hormone-receptor-positive early breast cancer](https://onco.cc/key-papers/paper-monarche-jco-2020/)
- terms: [Cell cycle](https://onco.cc/terms/cell-cycle/)
- biomarkers: [ER status (oestrogen receptor by IHC)](https://onco.cc/biomarkers/er-status/), [Ki-67 index (proliferation by IHC)](https://onco.cc/biomarkers/ki-67-index/)
- 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/abemaciclib.json