Elacestrant
Elacestrant was the first oral oestrogen-receptor degrader (2023), for ESR1-mutant breast cancer detected by blood test.
EMERALD: PFS benefit confined to ESR1-mutant disease; Guardant360 CDx as companion diagnostic. Stemline/Menarini. Imlunestrant (Lilly, Inluriyo, 2025) and camizestrant (AstraZeneca, SERENA-6 ctDNA-guided switch) followed.
1.Oral SERD binds ERα
- Route
- Oral
- Schedule
- 345 mg once daily with food
- Dose modifications
- Reduce to 258 then 172 mg for grade 3 toxicity
- Monitoring
- Lipids at baseline and periodically
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. 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. ESR1 mutation must be documented by an approved test.
- Assistance programmes
- 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.
- Notes
- Licensed 2023 for ESR1-mutated breast cancer; NICE appraisal 2024-25. Check NICE.
Sources: NICE search: elacestrant. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 27 Jan 2023ApprovalUS
ESR1-mutated ER+/HER2- advanced breast cancer after ≥1 endocrine therapy (EMERALD): first oral SERD source
- Sept 2023ApprovalEU
EMA approval source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2023 | ESR1-mutant ER+/HER2- advanced breast cancer after ≥1 endocrine therapy |
| Adverse event |
|---|
| Nausea |
| Musculoskeletal pain |
| Vomiting |
| Fatigue |
| Dyspepsia |
| Hypercholesterolaemia |
EMERALD: 35% any grade. Events listed without rates were not read from a primary source; see the label. 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 | — |
| United Kingdom | NICE: recommended for ESR1-mutated ER+/HER2- advanced breast cancer (2024) | 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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Latest papers
topQuery for this drug: (TITLE:"Elacestrant" OR ABSTRACT:"Elacestrant" OR TITLE:"Orserdu" OR ABSTRACT:"Orserdu") 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 Elacestrant, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductVepdegestrant
Shares ESR1 mutation, Hormone therapy, Oestrogen receptor signalling, Transcriptional machinery & addiction.
- ProductFulvestrant
Shares François-Clément Bidard, Oral SERD, Selective oestrogen receptor degrader (SERD), Estrogen receptor (ERα).
- ProductImlunestrant
Shares Oral SERD, ESR1 mutation, Estrogen receptor (ERα), Endocrine therapy (SERMs, AIs, SERDs).
- ProductCamizestrant
Shares Oral SERD, ESR1 mutation, Estrogen receptor (ERα), Endocrine therapy (SERMs, AIs, SERDs).
- TrialEMBER-3
Shares Oral SERD, ESR1 mutation, Estrogen receptor (ERα), HR-positive / HER2-negative breast cancer.
- TrialSERENA-6
Shares Selective oestrogen receptor degrader (SERD), ESR1 mutation, Estrogen receptor (ERα), Liquid biopsy (ctDNA).
- TermHormone receptor status (ER / PR)
Shares Selective oestrogen receptor degrader (SERD), Estrogen receptor (ERα), Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.
- ProductGiredestrant
Shares Oral SERD, Estrogen receptor (ERα), Endocrine therapy (SERMs, AIs, SERDs), HR-positive / HER2-negative breast cancer.