Enzalutamide
The most widely used androgen-receptor blocker, approved across every stage of advanced prostate cancer, including rising PSA after surgery.
AFFIRM and PREVAIL (mCRPC), PROSPER (nmCRPC), ARCHES and ENZAMET (mHSPC, OS benefit), EMBARK (high-risk BCR, 2023). Partner in TALAPRO-2 (talazoparib) and MEVPRO trials (mevrometostat). Fatigue, falls, and cognitive effects are the main toxicities.
- 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).
- 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.
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
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductAbiraterone acetate
Shares Howard I. Scher, Androgen receptor pathway inhibitor (ARPI), Prostate Cancer Foundation (PCF), mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer).
- ProductBicalutamide
Shares Androgen receptor pathway inhibitor (ARPI), Androgen deprivation & AR pathway inhibitors, Androgen receptor signalling, Androgen receptor.
- ProductApalutamide
Shares Charles L. Sawyers, Androgen deprivation & AR pathway inhibitors, Androgen receptor signalling, Androgen receptor.
- TermCastration-resistant prostate cancer (CRPC)
Shares Androgen receptor pathway inhibitor (ARPI), Prostate Cancer Foundation (PCF), mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer), Androgen receptor signalling.
- ProductMevrometostat
Shares MEVPRO-1, Lineage plasticity & neuroendocrine transformation, Androgen receptor, Pfizer (incl. Seagen).
- InstitutionStand Up To Cancer
Shares Howard I. Scher, Charles L. Sawyers, Prostate Cancer Foundation (PCF), Prostate cancer.
- PersonNeeraj Agarwal
Shares TALAPRO-2, Huntsman Cancer Institute, University of Utah, Androgen receptor, Prostate cancer.
- ProductTalazoparib
Shares TALAPRO-2, Huntsman Cancer Institute, University of Utah, Androgen receptor signalling, Pfizer (incl. Seagen).