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An AR blocker approved for prostate cancer that has spread and for high-risk disease before it shows on scans.
Apalutamide is a second-generation androgen receptor antagonist with lower CNS penetration than enzalutamide, intended to reduce seizures and cognitive effects while blocking the receptor as completely. It is given with androgen deprivation for non-metastatic castration-resistant prostate cancer and for metastatic hormone-sensitive disease. SPARTAN (nmCRPC) showed an overall survival benefit and TITAN (mHSPC) reduced deaths by about a third (OS HR 0.65), supporting the 2018 and 2019 approvals. Rash and hypothyroidism are its distinctive side effects and distinguish it from enzalutamide and darolutamide. There is no head-to-head trial among the three AR antagonists, so choice rests on side-effect profile and trial populations. In plain terms, it is an AR-blocking pill used both for cancer that has spread and for high-risk disease that has not yet shown on scans.
Second-generation AR antagonist with lower CNS penetration than enzalutamide. Connects to Androgen receptor.
1.Apalutamide acts on Androgen receptor, the hormone receptor or the enzyme that makes the hormone.
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.
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. Non-metastatic castration-resistant or metastatic castration-sensitive disease per the label.
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 TA740 · SMC advice: apalutamide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Non-metastatic CRPC (SPARTAN) |
| US | 2019 | mHSPC (TITAN) |
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Query for this drug: (TITLE:"Apalutamide" OR ABSTRACT:"Apalutamide" OR TITLE:"Erleada" OR ABSTRACT:"Erleada") 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 Apalutamide, not a curated reading list.
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 Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging, Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Androgen receptor signalling.
Shares A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC, mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer), Prostate cancer drugs in England: what NICE recommends, and what it refuses, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test.
Shares Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT, 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, An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC).
Shares Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging, Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test.
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 An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS, Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial, Salivary duct carcinoma, Non-metastatic castration-resistant prostate cancer.
Shares A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Metastatic hormone-sensitive prostate cancer.