Overview
Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), which is a negative regulator of T cell function. By blocking PD-1, cemiplimab works to enhance T cell-mediated antitumour responses. Cemiplimab was first approved by the FDA on September 28, 2018, as the first FDA-approved treatment for advanced cutaneous squamous cell carcinoma (CSCC). It was later approved to be used in basal cell carcinoma and non-small non-small cell lung cancer. Cemiplimab was also approved by the European Commission on June 28, 2019. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended cemiplimab be granted marketing authorization for the treatment of cervical cancer.
Background
Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), which is a negative regulator of T cell function. By blocking PD-1, cemiplimab works to enhance T cell-mediated antitumour responses. Cemiplimab was first approved by the FDA on September 28, 2018, as the first FDA-approved treatment for advanced cutaneous squamous cell carcinoma (CSCC). It was later approved to be used in basal cell carcinoma and non-small non-small cell lung cancer. Cemiplimab was also approved by the European Commission on June 28, 2019. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended cemiplimab be granted marketing authorization for the treatment of cervical cancer.
Indication
Cemiplimab is indicated to treat:
Associated Conditions
- Locally Advanced Basal Cell Carcinoma
- Locally Advanced Cutaneous Squamous Cell Carcinoma
- Locally Advanced Non-Small Cell Lung Cancer
- Metastatic Cervical Cancer
- Metastatic Non-Small Cell Lung Cancer
- Metastatic cutaneous squamous cell carcinoma
- Recurrent Cervical Cancer
- Metastatic Basal cell carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/13 | Phase 2 | Not yet recruiting | |||
2025/06/03 | Phase 2 | Not yet recruiting | |||
2025/05/20 | Phase 2 | Not yet recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | ||
2025/05/20 | Phase 2 | Not yet recruiting | |||
2025/04/24 | Phase 2 | Not yet recruiting | |||
2025/04/17 | Phase 3 | Not yet recruiting | |||
2025/04/09 | Phase 2 | Recruiting | |||
2025/04/08 | Phase 2 | Not yet recruiting | Fundación GECP | ||
2025/04/03 | Phase 3 | Not yet recruiting | |||
2025/03/30 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | 61755-008 | INTRAVENOUS | 50 mg in 1 mL | 3/4/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/28/2019 | ||
Authorised | 6/28/2019 |
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 |
|---|---|---|---|---|---|
| LIBTAYO cemiplimab 350 mg concentrate for solution for infusion | 320609 | Medicine | A | 7/17/2020 |