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
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