Overview
Retifanlimab is a humanized IgG4 kappa monoclonal antibody that binds to the programmed death receptor-1 (PD-1), blocking PD-1 interaction with its ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). By blocking the PD-1/PD-L1/2 pathway, retifanlimab potentiates T-cell activity and boosts the immune response against cancer cells. Other monoclonal antibodies that block PD-1 include pembrolizumab, nivolumab and cemiplimab. On October 2021, Incyte Biosciences withdrew its application for a marketing authorization of retifanlimab for the treatment of squamous carcinoma of the anal canal. On March 2023, the FDA granted accelerated approval to retifanlimab for a different indication, the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The use of retifanlimab in combination with other oncology drugs for the treatment of metastatic gastroesophageal adenocarcinoma has also been evaluated.
Background
Retifanlimab is a humanized IgG4 kappa monoclonal antibody that binds to the programmed death receptor-1 (PD-1), blocking PD-1 interaction with its ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). By blocking the PD-1/PD-L1/2 pathway, retifanlimab potentiates T-cell activity and boosts the immune response against cancer cells. Other monoclonal antibodies that block PD-1 include pembrolizumab, nivolumab and cemiplimab. On October 2021, Incyte Biosciences withdrew its application for a marketing authorization of retifanlimab for the treatment of squamous carcinoma of the anal canal. On March 2023, the FDA granted accelerated approval to retifanlimab for a different indication, the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The use of retifanlimab in combination with other oncology drugs for the treatment of metastatic gastroesophageal adenocarcinoma has also been evaluated.
Indication
Retifanlimab is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
Associated Conditions
- Metastatic Locally Advanced Merkel Cell Carcinoma
- Recurrent, locally advanced Merkel Cell Carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/06 | Phase 1 | Not yet recruiting | |||
2025/04/22 | Phase 1 | Recruiting | |||
2025/04/04 | N/A | AVAILABLE | |||
2025/03/26 | Phase 1 | Not yet recruiting | Anwaar Saeed | ||
2025/03/13 | Phase 1 | Recruiting | |||
2024/04/29 | Phase 2 | Recruiting | |||
2024/03/20 | Phase 1 | Recruiting | |||
2023/12/21 | Phase 1 | Recruiting | |||
2023/12/07 | Phase 2 | Recruiting | Academic and Community Cancer Research United | ||
2023/11/29 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Incyte Corporation | 50881-006 | INTRAVENOUS | 25 mg in 1 mL | 11/10/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/19/2024 | ||
Authorised | 4/19/2024 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||