Overview
Ipilimumab is a fully humanized IgG1 monoclonal antibody that blocks cytotoxic T lymphocyte antigen-4 (CTLA-4). Blocking CTLA-4 removes an inhibitory signal from reducing the activity of T lymphocytes. Ipilimumab was developed by Bristol-Myers Squibb and Medarex. Ipilimumab was granted FDA approval on 25 March 2011.
Background
Ipilimumab is a fully humanized IgG1 monoclonal antibody that blocks cytotoxic T lymphocyte antigen-4 (CTLA-4). Blocking CTLA-4 removes an inhibitory signal from reducing the activity of T lymphocytes. Ipilimumab was developed by Bristol-Myers Squibb and Medarex. Ipilimumab was granted FDA approval on 25 March 2011.
Indication
Ipilimumab is indicated in the following cancerous conditions: Melanoma Renal Cell Carcinoma (RCC) Colorectal Cancer Hepatocellular Carcinoma Non-Small Cell Lung Cancer (NSCLC) Malignant Pleural Mesothelioma Esophageal Cancer - Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab
Associated Conditions
- Cutaneous Melanoma
- Hepatocellular Carcinoma
- Metastatic Esophageal Squamous Cell Carcinoma
- Metastatic Melanoma
- Metastatic Non-Small Cell Lung Cancer
- Microsatellite Instability High Metastatic Colorectal Cancer (CRC)
- Mismatch Repair-deficient (dMMR) Metastatic Colorectal Cancer (CRC)
- Recurrent Non-small Cell Lung Cancer
- Unresectable Melanoma
- Poor or intermediate risk Advanced Renal Cell Carcinoma (aRCC)
- Unresectable Malignant Pleural Mesothelioma (MPM)
- Unresectable, advanced Esophageal Squamous Cell Carcinoma (ESCC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/02 | Phase 3 | Not yet recruiting | |||
2025/05/13 | Phase 1 | Not yet recruiting | |||
2025/04/27 | Phase 2 | Recruiting | |||
2025/04/24 | Phase 2 | Not yet recruiting | |||
2025/03/21 | Phase 1 | Recruiting | Aman Chauhan, MD | ||
2025/03/10 | Phase 1 | Recruiting | |||
2025/03/05 | Phase 1 | Recruiting | |||
2025/02/24 | Phase 3 | Not yet recruiting | Shanghai Henlius Biotech | ||
2025/01/24 | Phase 2 | Terminated | |||
2025/01/20 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| E.R. Squibb & Sons, L.L.C. | 0003-2328 | INTRAVENOUS | 5 mg in 1 mL | 3/19/2015 | |
| E.R. Squibb & Sons, L.L.C. | 0003-2327 | INTRAVENOUS | 5 mg in 1 mL | 3/19/2015 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/13/2011 | ||
Authorised | 7/13/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| YERVOY INJECTION CONCENTRATE 5MG/ML | SIN14598P | INJECTION, SOLUTION, CONCENTRATE | 5mg/ml | 8/29/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ipilimumab Injection | 国药准字SJ20210020 | 生物制品 | 注射剂 | 6/8/2021 | |
| Ipilimumab Injection | 国药准字SJ20210019 | 生物制品 | 注射剂 | 6/8/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| WINGLORE ipilimumab (rch) 50mg in 10mL (5mg/mL) concentrate solution for IV infusion vial | 174326 | Medicine | A | 7/4/2011 | |
| YERVOY ipilimumab (rch) 50mg in 10mL (5mg/mL) concentrate solution for IV infusion vial | 174319 | Medicine | A | 7/4/2011 | |
| YERVOY ipilimumab (rch) 200mg in 40mL (5mg/mL) concentrate solution for IV infusion vial | 174322 | Medicine | A | 7/4/2011 | |
| WINGLORE ipilimumab (rch) 200mg in 40mL (5mg/mL) concentrate solution for IV infusion vial | 174327 | Medicine | A | 7/4/2011 |