YERVOY
Yervoy (ipilimumab) is a CTLA-4-directed blocking antibody indicated for the treatment of various advanced or metastatic malignancies, including melanoma, renal cell carcinoma, and non-small cell lung cancer. It is utilized as a monotherapy or in combination with nivolumab, and in some instances with chemotherapy, depending on the specific cancer type and patient history. The therapy is approved for adult populations and, for specific indications such as melanoma and colorectal cancer, for pediatric patients aged 12 years and older. Its clinical application ranges from first-line treatment of metastatic disease to adjuvant therapy following surgical resection.
How YERVOY Works
Ipilimumab is a monoclonal antibody that binds to CTLA-4, a molecule that acts as a negative regulator to suppress T-cell activity. By blocking the interaction between CTLA-4 and its ligands, CD80 and CD86, the drug augments the activation and proliferation of T-effector cells that infiltrate tumors. Additionally, the inhibition of CTLA-4 signaling reduces the suppressive function of T-regulatory cells. These combined actions result in a general increase in T-cell responsiveness and strengthen the body's anti-tumor immune response.
Details
- Status
- Prescription
- First Approved
- 2011-03-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
YERVOY Approval History
What YERVOY Treats
9 indicationsYERVOY is approved for 9 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unresectable or metastatic melanoma
- Adjuvant treatment of cutaneous melanoma with regional lymph node involvement following complete resection
- Intermediate or poor risk advanced renal cell carcinoma
- Unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer
- Unresectable or metastatic hepatocellular carcinoma
- Metastatic non-small cell lung cancer expressing PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations
- Metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations
- Unresectable malignant pleural mesothelioma
YERVOY Target & Pathway
ProTarget
An immune checkpoint receptor that downregulates T-cell activation. Unlike PD-1 which works in peripheral tissues, CTLA-4 primarily regulates T-cell activation in lymph nodes. Blocking CTLA-4 enhances T-cell activation and proliferation, boosting anti-tumor immunity.
YERVOY Competitors
Pro1 other drug also targets CTLA-4. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CTLA-4). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
YERVOY FDA Label Details
ProIndications & Usage
FDA Label (PDF)YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. • Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. Renal Cell Carcinoma (RCC) • Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treat...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.