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Elacestrant was the first oral oestrogen-receptor degrader (2023), for ESR1-mutant breast cancer detected by blood test.
Elacestrant is an oral selective oestrogen receptor degrader (SERD) that binds ER-alpha and promotes its degradation, retaining activity against ESR1 mutations. Taken as 345 mg once daily with food, it was approved in 2023, the first oral SERD, for ESR1-mutant ER-positive, HER2-negative advanced breast cancer after at least one endocrine therapy. In EMERALD the progression-free survival benefit was confined to ESR1-mutant disease, and the Guardant360 CDx blood test is the companion diagnostic, so eligibility is decided by liquid biopsy. Stemline/Menarini markets it. Imlunestrant (Lilly, Inluriyo, 2025) and camizestrant (AstraZeneca, SERENA-6 ctDNA-guided switch) followed, and whether to switch when an ESR1 mutation first appears in blood is the live question. For a newcomer: an oestrogen-blocking pill chosen by a blood test.
Oral selective ER degrader. Connects to Estrogen receptor (ERα).
1.Oral SERD binds ERα
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. 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. ESR1 mutation must be documented by an approved test.
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 TA1036. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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ESR1-mutated ER+/HER2- advanced breast cancer after ≥1 endocrine therapy (EMERALD): first oral SERD source
EMA approval source
| 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.
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Query 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.
Shares Oral SERDs, Oral SERD, ESR1 mutation (ligand-binding domain, usually in ctDNA), ESR1 mutation.
Shares Oral SERDs, Oral SERD, ESR1 mutation (ligand-binding domain, usually in ctDNA), ESR1 mutation.
Shares Oral SERDs, ESR1 mutation, Oestrogen receptor signalling, Hormone therapy.
Shares Oral SERD, ESR1 mutation, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα).
Shares Oral SERDs, Oral SERD, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα).
Shares Selective oestrogen receptor degrader (SERD), ESR1 mutation, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα).
Shares Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer, ER status (oestrogen receptor by IHC), Chemical carcinogenesis - receptor activation, Breast cancer (KEGG map).
Shares François-Clément Bidard, Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer, Oral SERD, Selective oestrogen receptor degrader (SERD).