FDA label
What is Xtandi used for?
Xtandi contains enzalutamide. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “XTANDI® is indicated for the treatment of patients with: castration-resistant prostate cancer (CRPC); metastatic castration-sensitive prostate cancer (mCSPC); non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).”
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Xtandi, tablet
Indications and Usage, quoted from the label by Astellas Pharma US, Inc. (NDA213674). Cross-references to other label sections are left out.
XTANDI® is indicated for the treatment of patients with:
- castration-resistant prostate cancer (CRPC)
- metastatic castration-sensitive prostate cancer (mCSPC)
- non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)
Source: DailyMed label, set id b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf, version 24, effective July 28, 2026. NDC 0469-0625, one of 3 listings for this product.
Questions
What is Xtandi used for?
The FDA label says: “XTANDI® is indicated for the treatment of patients with: castration-resistant prostate cancer (CRPC); metastatic castration-sensitive prostate cancer (mCSPC); non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).”
What drug class is Xtandi?
FDA lists enzalutamide in the Androgen Receptor Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.