Enzalutamide
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.
Overview
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.
1.Enzalutamide acts on its target, the hormone receptor or the enzyme that makes the hormone.
- 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). Xtandi was selected for Medicare price negotiation in January 2025; the negotiated price takes effect 1 January 2027.
- Commercial insurance
- step therapy common
Covered with prior authorisation; several PBMs require a trial of generic abiraterone first in metastatic castration-resistant disease unless abiraterone is contraindicated.
- Assistance programmes
- Astellas Pharma Support Solutions
- Pfizer Oncology Together
- Pfizer RxPathways
- 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) · CMS: Medicare Drug Price Negotiation Program. Not medical or financial advice; verify with your plan.
- Appraised for
- Metastatic castration-resistant prostate cancer after docetaxel
- Notes
- Before chemotherapy: TA377 (2016). Hormone-sensitive metastatic disease: TA712 (2021). Non-metastatic CRPC: TA580 (2019). Non-metastatic prostate cancer after radical prostatectomy or radiotherapy: TA994 (August 2024), terminated appraisal.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA316 · SMC advice: enzalutamide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 24 Jul 2026Label changeUS
US Prescribing Information updated with overall survival data from EMBARK (NDA 203415/S-026, NDA 213674/S-016; efficacy labelling change with clinical data) source
Approvals
| 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) |
Trials
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Landmark trials
Latest papers
topQuery for this drug: (TITLE:"Enzalutamide" OR ABSTRACT:"Enzalutamide" OR TITLE:"Xtandi" OR ABSTRACT:"Xtandi") AND (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR 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.
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