BLAINTRAVENOUSINJECTABLEPriority Review
Approved
May 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
BAVENCIO (avelumab) by EMD Serono Research & Development Institute, Inc. is pd-l1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. First approved in 2017.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BAVENCIO (avelumab) is a human monoclonal antibody (mAb) that binds programmed death ligand-1 (PD-L1) to restore anti-tumor immune responses. It is indicated for multiple oncology indications including Merkel cell carcinoma and urothelial carcinoma. The drug works by blocking PD-L1 interaction with PD-1 and B7.1 receptors, releasing T-cell inhibition and enabling cytotoxic immune activity; it also induces antibody-dependent cell-mediated cytotoxicity (ADCC).
$0.002BPart D
PeakProduct is at peak commercial maturity with modest Part D penetration, suggesting a stable but not rapidly expanding commercial organization.
Mechanism of Action
PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
Started Dec 2025
25 enrolled
Penile Squamous Cell Carcinoma (PSCC)
Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
Started Jun 2025
0Advanced Urothelial Carcinoma
Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19.
Started Feb 2025
67 enrolled
Head and Neck Squamous Cell Carcinoma (HNSCC)Recurrent Head and Neck CancerMetastatic Head and Neck Cancer
Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab Maintenance and Pembrolizumab Second-Line Therapy in Advanced Urothelial Cancer.
Started Sep 2024
35 enrolled
Urothelial Cancer
Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)
Started Aug 2024
0Urothelial Carcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.