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Abemaciclib was the first CDK4/6 inhibitor approved after surgery for high-risk hormone-positive breast cancer.
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.
CDK4-biased inhibitor with continuous dosing. Connects to CDK4/6.
1.Oral drug is absorbed and reaches the tumour
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Adjuvant use requires documentation of the high-risk node-positive criteria in the label.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA563 · SMC advice: abemaciclib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
With fulvestrant after endocrine therapy, and as monotherapy after chemotherapy (MONARCH 2/1) source
With aromatase inhibitor first line (MONARCH 3) source
Adjuvant high-risk node-positive HR+/HER2- early breast cancer, Ki-67 ≥20% (monarchE) source
Adjuvant indication broadened to remove Ki-67 requirement source
With imlunestrant, for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer source
| Region | Year | Indication |
|---|---|---|
| US | 2017 | HR+/HER2- advanced breast cancer |
| US | 2021 | Adjuvant high-risk node-positive HR+/HER2- early breast cancer |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea 81-90% any grade; 8-20% grade 3 across trials | 85% | 8% |
| Neutropenia 37-46% any grade; 19-32% grade 3-4 | 42% | 19% |
| Infections monarchE / MONARCH 2 | - | 3% |
| Venous thromboembolism 2-5% across trials | - | 2% |
| Interstitial lung disease monarchE / MONARCH 2 | - | 0.5% |
| Fatigue monarchE / MONARCH 2 | - | - |
| Nausea monarchE / MONARCH 2 | - | - |
| Anaemia monarchE / MONARCH 2 | - | - |
| ALT increased monarchE / MONARCH 2 | - | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (cdk4/6 inhibitors) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | lillycares.com |
| United Kingdom | NICE: recommended with fulvestrant (TA579), aromatase inhibitor (TA563), and adjuvant (TA810) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Abemaciclib" OR ABSTRACT:"Abemaciclib" OR TITLE:"Verzenio" OR ABSTRACT:"Verzenio") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Abemaciclib, not a curated reading list.
Shares A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC, A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With , 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, 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).
Shares A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC, A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With , 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, 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).
Shares Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer, 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, A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer.
Shares 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, A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer, A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, 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.
Shares MONARCH 3, Study of AVZO-021 in Patients With Advanced Solid Tumors, GLP-1 receptor agonists as adjuvant weight-loss therapy in HR-positive breast cancer, ER status (oestrogen receptor by IHC).
Shares Matthew P. Goetz, Stephen Johnston, Komal Jhaveri, EMBER-3.
Shares 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, CDK4-selective inhibitors as the new first-line backbone, The cell-cycle engine (cyclins & CDKs), HR-positive metastatic breast cancer after CDK4/6 inhibitors.
Shares A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With , Oral SERD + CDK4/6 inhibitor after ESR1 emergence, 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, Breast cancer (KEGG map).