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AVELUMAB
Avelumab binds to PD-L1, blocking its interaction with PD-1 and B7.1 receptors, restoring immune responses against tumors.
Avelumab is a marketed immunotherapy that targets PD-L1, currently approved for metastatic Merkel Cell Carcinoma. Its key strength lies in its mechanism of action, which effectively restores immune responses against tumors by blocking the interaction between PD-L1 and PD-1/B7.1 receptors. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | AVELUMAB |
|---|---|
| Drug class | Programmed Death Ligand-1 Blocker [EPC] |
| Target | PD-L1 |
| Modality | Monoclonal antibody |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Avelumab works by targeting PD-L1, a protein that can inhibit the immune system's ability to fight cancer. By blocking PD-L1, Avelumab helps restore the immune system's function, allowing it to more effectively attack tumor cells. Additionally, Avelumab can trigger the destruction of tumor cells through a process called antibody-dependent cell-mediated cytotoxicity (ADCC).
Approved indications
- Metastatic Merkel Cell Carcinoma
- First-Line Maintenance Urothelial Carcinoma
- Previously-Treated Urothelial Carcinoma
- Advanced Renal Cell Carcinoma
Common side effects
- Fatigue
- Infusion-related reaction
- Edema
- Musculoskeletal pain
- Arthralgia
Key clinical trials
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- Targeted Therapy and Avelumab in Merkel Cell Carcinoma (PHASE1, PHASE2)
- A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy (PHASE2)
- Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy (PHASE1, PHASE2)
- Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study (PHASE3)
- Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial (PHASE2)
- Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies (PHASE1, PHASE2)
- Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AVELUMAB CI brief — competitive landscape report
- AVELUMAB updates RSS · CI watch RSS