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Enzalutamide is a second-generation androgen-receptor blocker that stops the receptor binding testosterone, entering the nucleus and switching on genes. It is approved at every stage of advanced prostate cancer, from rising PSA after surgery to castration-resistant disease, and fatigue, falls and memory problems are its main drawbacks.
Enzalutamide is a second-generation androgen receptor antagonist that blocks ligand binding, nuclear translocation and DNA binding, giving more complete AR blockade than older antiandrogens. It is approved across every stage of advanced prostate cancer: AFFIRM and PREVAIL (mCRPC), PROSPER (nmCRPC), ARCHES and ENZAMET (mHSPC, overall survival benefit; ARCHES OS HR 0.66) and EMBARK (high-risk biochemical recurrence, 2023, metastasis-free survival HR 0.42 with leuprolide). It is the partner in TALAPRO-2 (talazoparib) and the MEVPRO trials (mevrometostat), so the next generation of combinations is built on it. Fatigue, falls and cognitive effects are the main toxicities, which is why darolutamide or apalutamide is sometimes preferred in frail men. For a newcomer, enzalutamide is the most widely used androgen-receptor blocker, from rising PSA after surgery to late-stage disease.
Second-generation AR antagonist blocking ligand binding, nuclear translocation, and DNA binding. Connects to Androgen receptor.
1.Enzalutamide acts on Androgen receptor, the hormone receptor or the enzyme that makes the hormone.
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). Xtandi was selected for Medicare price negotiation in January 2025; the negotiated price takes effect 1 January 2027.
Covered with prior authorisation; several PBMs require a trial of generic abiraterone first in metastatic castration-resistant disease unless abiraterone is contraindicated.
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) · CMS: Medicare Drug Price Negotiation Program. Not medical or financial advice; verify with your plan.
Sources: NICE TA316 · SMC advice: enzalutamide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Region | Year | Indication |
|---|---|---|
| US | 2012 | mCRPC after docetaxel (pre-chemo 2014) |
| US | 2018 | Non-metastatic CRPC |
| US | 2019 | mHSPC (ARCHES) |
| US | 2023 | High-risk biochemical recurrence (EMBARK) |
Read for the class this product belongs to (androgen deprivation) 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.
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Enzalutamide, with or without androgen deprivation, is now approved for high-risk biochemical recurrence, and intermittent therapy with treatment suspension is built into the regimen.
The randomised proof for PARP inhibition in BRCA-altered prostate cancer, and the clearest evidence that the homologous recombination repair gene list should not be used as a single yes-or-no test. ATM-altered disease needs a different answer, and does not yet have one.
Two years of abiraterone with androgen deprivation and radiotherapy is the standard for very high-risk and node-positive localised prostate cancer.
The first randomised evidence that the order in which prostate cancer treatments are given changes how long they work, independently of which treatments they are. It is also a rare trial in which quality of life pointed one way and the primary endpoint pointed nowhere.
It shows that the useful information in a castration-resistant plasma sample is in the repair genes and TP53 rather than in the androgen receptor finding that dominates the report, and it is the closest thing the field has to a head-to-head comparison of abiraterone against enzalutamide.
Enzalutamide works modestly in AR-positive TNBC and is the reference for the LAR subtype's therapy implication; the AR threshold used for eligibility changes who counts as positive.
Enzalutamide is one of three androgen receptor inhibitors standard for high-risk non-metastatic castration-resistant prostate cancer.
A demonstration that a drug that has stopped working can be made to work again by changing the environment the tumour has adapted to, rather than by changing the drug. It is the strongest clinical evidence in prostate cancer for treating resistance as something reversible.
Query for this drug: (TITLE:"Enzalutamide" OR ABSTRACT:"Enzalutamide" OR TITLE:"Xtandi" OR ABSTRACT:"Xtandi") 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 Enzalutamide, not a curated reading list.
Shares An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Canc, A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer, A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA, A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study.
Shares ARMOR3-SV, Prostate Cancer Foundation (PCF), KEYNOTE-641, PREVAIL.
Shares Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer., Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer, AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01), Disease volume (CHAARTED high-volume versus low-volume) and LATITUDE risk.
Shares Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer, AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01), Disease volume (CHAARTED high-volume versus low-volume) and LATITUDE risk, PSA kinetics: PSA doubling time and PSA density.
Shares Androgen receptor-positive triple-negative breast cancer, Apocrine carcinoma of the breast, Luminal androgen receptor triple-negative breast cancer (LAR), Molecular determinants of resistance to antiandrogen therapy.
Shares ARMOR3-SV, AR-V7 splice variant, CARD, Bipolar androgen therapy (BAT).
Shares A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer., This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking En, MEVPRO-1, Lineage plasticity & neuroendocrine transformation.
Shares PROSPER: enzalutamide in men with non-metastatic castration-resistant prostate cancer, RESTORE: bipolar androgen therapy after progression on enzalutamide in metastatic castration-resistant prostate cancer, PREVAIL: enzalutamide in metastatic prostate cancer before chemotherapy, AFFIRM: increased survival with enzalutamide in prostate cancer after chemotherapy.