Abemaciclib
Abemaciclib was the first CDK4/6 inhibitor approved after surgery for high-risk hormone-positive breast cancer.
MONARCH 2/3 (OS benefit in MONARCH 2), monarchE (adjuvant, iDFS HR 0.68 at 5 years; approved 2021, label broadened 2023). Continuous dosing; diarrhoea is the main toxicity. Eli Lilly.
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral, continuous
- Schedule
- 150 mg twice daily with endocrine therapy (2 years adjuvant); 200 mg twice daily as monotherapy
- Dose modifications
- Reduce to 100 then 50 mg BID for grade 3 diarrhoea, neutropenia, hepatotoxicity; loperamide at first loose stool
- Monitoring
- Blood counts and LFTs every 2 weeks for 2 months then monthly; VTE and ILD symptoms
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Lilly Cares Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- With an aromatase inhibitor for untreated HR-positive, HER2-negative advanced breast cancer
- Notes
- With fulvestrant: TA579 (2019). Adjuvant use for high-risk early breast cancer (monarchE): TA810 (2022).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA563 · SMC advice: abemaciclib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 28 Sept 2017ApprovalUS
With fulvestrant after endocrine therapy, and as monotherapy after chemotherapy (MONARCH 2/1) source
- 26 Feb 2018ApprovalUS
With aromatase inhibitor first line (MONARCH 3) source
- 12 Oct 2021ApprovalUS
Adjuvant high-risk node-positive HR+/HER2- early breast cancer, Ki-67 ≥20% (monarchE) source
- 3 Mar 2023Label changeUS
Adjuvant indication broadened to remove Ki-67 requirement source
Approvals
| 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.
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductRibociclib
Shares CDK4-selective inhibitors as the new first-line backbone, CDK4/6 inhibitor + endocrine therapy, Cell cycle, The cell-cycle engine (cyclins & CDKs).
- ProductPalbociclib
Shares CDK4-selective inhibitors as the new first-line backbone, CDK4/6 inhibitor + endocrine therapy, Miguel Martín, Cell cycle.
- ProductAtirmociclib
Shares CDK4-selective inhibitors as the new first-line backbone, The cell-cycle engine (cyclins & CDKs), CDK4/6 inhibitors, CDK4/6.
- ProductImlunestrant
Shares EMBER-3, Oral SERD + CDK4/6 inhibitor after ESR1 emergence, Eli Lilly (incl. Loxo), HR-positive / HER2-negative breast cancer.
- Key paperNATALEE: three years of ribociclib after surgery in a broad population of hormone-receptor-positive early breast cancer
Shares monarchE, Miguel Martín, CDK4/6 inhibitors, CDK4/6.
- ProductLetrozole (and other aromatase inhibitors)
Shares MONARCH 3, GLP-1 receptor agonists as adjuvant weight-loss therapy in HR-positive breast cancer, Oestrogen receptor signalling, Endometrial cancer.
- TargetWEE1
Shares Cell cycle, The cell-cycle engine (cyclins & CDKs), p53 / RB / cell-cycle checkpoint, Endometrial cancer.
- TermHallmark: evading growth suppressors
Shares The cell-cycle engine (cyclins & CDKs), CDK4/6 inhibitors, CDK4/6, p53 / RB / cell-cycle checkpoint.