Overview
Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells. Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy. On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Indication
Durvalumab is indicated for the treatment of adults with the following conditions:
Associated Conditions
- Extensive-stage Small Cell Lung Cancer (SCLC)
- Locally Advanced Biliary Tract Cancer
- Metastatic Biliary Tract Cancer
- Metastatic Non-Small Cell Lung Cancer
- Unresectable Hepatocellular Carcinoma (HCC)
- Unresectable Stage III Non-small Cell Lung Cancer
- Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/14 | Not Applicable | Not yet recruiting | |||
2025/08/08 | Not Applicable | Not yet recruiting | |||
2025/08/06 | Not Applicable | Not yet recruiting | |||
2025/07/23 | Not Applicable | Not yet recruiting | |||
2025/06/10 | Phase 2 | Not yet recruiting | |||
2025/06/05 | Phase 3 | Recruiting | |||
2025/05/31 | Phase 2 | Not yet recruiting | Chang Gung Memorial Hospital | ||
2025/05/31 | Phase 2 | Not yet recruiting | Bi Nan | ||
2025/05/31 | Phase 2 | Recruiting | Chang Gung Memorial Hospital | ||
2025/05/29 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AstraZeneca Pharmaceuticals LP | 0310-4611 | INTRAVENOUS | 500 mg in 10 mL | 6/16/2023 | |
AstraZeneca Pharmaceuticals LP | 0310-4500 | INTRAVENOUS | 120 mg in 2.4 mL | 6/16/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 9/21/2018 | ||
Authorised | 9/21/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML | SIN15569P | INFUSION, SOLUTION CONCENTRATE | 50 mg/ml | 10/29/2018 |
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 |
---|---|---|---|---|---|
IMFINZI durvalumab (rch) 500 mg concentrated injection vial | 283216 | Medicine | A | 10/1/2018 | |
IMFINZI durvalumab (rch) 120 mg concentrated injection vial | 283215 | Medicine | A | 10/1/2018 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
IMFINZI | astrazeneca canada inc | 02468816 | Solution - Intravenous | 50 MG / ML | 11/20/2017 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
IMFINZI 50 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1181322001IP | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
IMFINZI 50 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1181322001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
IMFINZI 50 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1181322002IP | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
IMFINZI 50 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1181322002 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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