FDA label
What is Inlyta used for?
Inlyta contains axitinib. 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 for Inlyta lists 2 uses: First-Line Advanced Renal Cell Carcinoma; Second-Line Advanced Renal Cell Carcinoma.
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Inlyta, tablet, film coated
Indications and Usage, quoted from the label by U.S. Pharmaceuticals (NDA202324). Cross-references to other label sections are left out.
First-Line Advanced Renal Cell Carcinoma
INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC.
Second-Line Advanced Renal Cell Carcinoma
INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.
Source: DailyMed label, set id 8a903e31-936e-4ed7-8a59-59f32374f338, version 12, effective March 12, 2026. NDC 63539-026, one of 4 listings for this product.
Questions
What is Inlyta used for?
The FDA label for Inlyta lists 2 uses: First-Line Advanced Renal Cell Carcinoma; Second-Line Advanced Renal Cell Carcinoma.
What drug class is Inlyta?
FDA lists axitinib in the Kinase 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.