INLYTA
INLYTA (axitinib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma (RCC). It is approved for use as a first-line therapy in combination with either avelumab or pembrolizumab. Additionally, the drug is indicated as a single agent for patients with advanced RCC following the failure of one prior systemic therapy. This medication serves as both a combination partner in initial treatment and a monotherapy option in the second-line setting.
How INLYTA Works
Axitinib functions by inhibiting specific receptor tyrosine kinases, specifically vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, and VEGFR-3. These receptors are involved in pathologic angiogenesis, tumor growth, and the progression of cancer. By blocking these targets, the drug inhibits the proliferation and survival of endothelial cells mediated by VEGF. This action results in the inhibition of tumor growth and the phosphorylation of VEGFR-2.
Details
- Status
- Prescription
- First Approved
- 2012-01-27
- Routes
- ORAL
- Dosage Forms
- TABLET
INLYTA Approval History
What INLYTA Treats
3 indicationsINLYTA is approved for 3 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- First-line treatment of advanced renal cell carcinoma in combination with avelumab
- First-line treatment of advanced renal cell carcinoma in combination with pembrolizumab
- Advanced renal cell carcinoma after failure of one prior systemic therapy
INLYTA Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
INLYTA Competitors
Pro2 other drugs also target VEGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (VEGFR). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INLYTA FDA Label Details
ProIndications & Usage
FDA Label (PDF)INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. 1.1 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 indi...
INLYTA Patents & Exclusivity
Patents (24 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.