Overview
Avelumab is a human IgG1 lambda monoclonal antibody that binds programmed cell death ligand-1 (PD-L1) to block its interaction with its receptors found on T cells and antigen-presenting cells. Avelumab was first approved by the FDA on March 23, 2017. On September 18 and December 18 of the same year, it was also granted approval by EMA and Health Canada, respectively. It is used in the treatment of Merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma.
Background
Avelumab is a human IgG1 lambda monoclonal antibody that binds programmed cell death ligand-1 (PD-L1) to block its interaction with its receptors found on T cells and antigen-presenting cells. Avelumab was first approved by the FDA on March 23, 2017. On September 18 and December 18 of the same year, it was also granted approval by EMA and Health Canada, respectively. It is used in the treatment of Merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma.
Indication
Avelumab is indicated for the treatment of adults with metastatic Merkel cell carcinoma (MCC). In the US, it is also used in patients 12 years and older. It is also indicated as the maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (UC), which has not progressed with first-line platinum-containing chemotherapy. In the US, avelumab is also indicated to treat locally advanced or metastatic UC with disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Avelumab is indicated, in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma (RCC).
Associated Conditions
- Advanced Renal Cell Carcinoma
- Metastatic Urothelial Cancer
- Locally advanced Urothelial Carcinoma
- Metastatic Merkel Cell Carcinoma (MCC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/22 | Phase 1 | Recruiting | |||
2025/03/25 | Phase 2 | Recruiting | |||
2025/02/11 | Phase 4 | Recruiting | |||
2024/10/15 | Phase 2 | Recruiting | Groupe Oncologie Radiotherapie Tete et Cou | ||
2024/08/16 | Phase 2 | Not yet recruiting | |||
2024/07/24 | Phase 2 | Recruiting | Panagiotis Konstantinopoulos, MD, PhD | ||
2024/05/22 | Phase 2 | Not yet recruiting | |||
2024/05/14 | N/A | Active, not recruiting | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | ||
2024/01/29 | Phase 2 | Recruiting | |||
2024/01/26 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| EMD Serono, Inc. | 44087-3535 | INTRAVENOUS | 20 mg in 1 mL | 3/19/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/18/2017 | ||
Authorised | 9/18/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BAVENCIO CONCENTRATE FOR SOLUTION FOR INFUSION 200MG/10ML | SIN15672P | INJECTION, SOLUTION, CONCENTRATE | 200mg/10ml | 4/25/2019 |
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 |
|---|---|---|---|---|---|
| BAVENCIO avelumab (rch) 200 mg/10 mL concentrated solution for intravenous infusion vial | 282729 | Medicine | A | 1/3/2018 |