BAVENCIO
Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of several advanced malignancies. It is used for metastatic Merkel cell carcinoma in adults and pediatric patients aged 12 and older, and as a first-line treatment for advanced renal cell carcinoma in combination with axitinib. The drug is also indicated for patients with locally advanced or metastatic urothelial carcinoma, both as a maintenance treatment following platinum-containing chemotherapy and for disease that has progressed during or after such therapy.
How BAVENCIO Works
Avelumab binds to PD-L1, a protein expressed on tumor cells that suppresses the immune system by interacting with receptors on T cells. By blocking the interaction between PD-L1 and the PD-1 and B7.1 receptors, the drug releases the inhibitory effects on T-cell activity and proliferation. This mechanism restores the body's anti-tumor immune response and allows for increased cytokine production. Additionally, the drug has been shown to induce antibody-dependent cell-mediated cytotoxicity against target cells in vitro.
Details
- Status
- Prescription
- First Approved
- 2017-03-23
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE
BAVENCIO Approval History
What BAVENCIO Treats
5 indicationsBAVENCIO is approved for 5 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Merkel cell carcinoma in adults and pediatric patients 12 years and older
- Maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy
- Locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy
- Locally advanced or metastatic urothelial carcinoma with disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- First-line treatment of advanced renal cell carcinoma in combination with axitinib
BAVENCIO Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
BAVENCIO Competitors
Pro10 other drugs also target PD-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (PD-1). Earlier expiry dates signal biosimilar/generic opportunities.
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.
BAVENCIO FDA Label Details
ProIndications & Usage
FDA Label (PDF)BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC. Urothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. Patients with locally advanced or metastatic UC who: Have disease progression during or following platinum-containing chemotherapy. Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.