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DURVALUMAB
DURVALUMAB is a Programmed Death Ligand-1 Blocker [EPC] drug. It is currently FDA-approved (first approved 2017) for Resectable NSCLC, Unresectable Stage III NSCLC, Metastatic NSCLC.
Durvalumab binds to PD-L1, blocking its interaction with PD-1 and CD80, enhancing T-cell activation and reducing tumor size.
Durvalumab is a programmed cell death 1 ligand 1 inhibitor, classified as an INHIBITOR drug modality, and is an antibody. It is being studied in clinical trials for various stages of breast cancer, including Anatomic Stage II, IIA, IIB, III, and IIIA.
At a glance
| Generic name | DURVALUMAB |
|---|---|
| Drug class | Programmed Death Ligand-1 Blocker [EPC] |
| Target | PD-L1 |
| Modality | Monoclonal antibody |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Durvalumab works by binding to PD-L1, a protein that can be induced by inflammation and is found on tumor and immune cells. By blocking PD-L1 from interacting with its receptors (PD-1 and CD80), it helps T-cells become more active, leading to better immune responses against tumors.
Approved indications
- Resectable NSCLC
- Unresectable Stage III NSCLC
- Metastatic NSCLC
- Limited-Stage SCLC
- Extensive-Stage SCLC
- Locally Advanced or Metastatic BTC
- Unresectable HCC
- Advanced or Recurrent Endometrial Cancer
- Muscle Invasive Bladder Cancer
- Resectable GC/GEJC
Common side effects
- Pneumonitis/Radiation Pneumonitis
- Cough
- Fatigue
- Upper Respiratory Tract Infections
- Dyspnea
- Rash
- Nausea
- Fatigue/Asthenia
- Alopecia
- Pneumonia
- Diarrhea
- Abdominal Pain
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial (PHASE3)
- Durvalumab as Consolidation for Patients LS-SCLC (PHASE2)
- Durvalumab With Gemcitabine and Cisplatin for the Treatment of High-Risk Resectable Liver Cancer Before Surgery (PHASE2)
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer (PHASE2)
- MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma (PHASE2)
- Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy (PHASE2)
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:
- DURVALUMAB CI brief — competitive landscape report
- DURVALUMAB updates RSS · CI watch RSS
Frequently asked questions about DURVALUMAB
What is DURVALUMAB?
How does DURVALUMAB work?
What is DURVALUMAB used for?
What drug class is DURVALUMAB in?
When was DURVALUMAB approved?
What development phase is DURVALUMAB in?
What are the side effects of DURVALUMAB?
What does DURVALUMAB target?
Related
- Drug class: All Programmed Death Ligand-1 Blocker [EPC] drugs
- Target: All drugs targeting PD-L1
- Indication: Drugs for Resectable NSCLC
- Indication: Drugs for Unresectable Stage III NSCLC
- Indication: Drugs for Metastatic NSCLC
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing