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).
Background
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 |
|---|---|---|---|---|---|
2025/06/10 | Phase 2 | Not yet recruiting | |||
2025/06/05 | Phase 3 | Not yet 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 | |||
2025/05/28 | Phase 3 | Not yet recruiting | |||
2025/05/09 | Phase 1 | Recruiting | |||
2025/05/07 | Phase 3 | Recruiting | |||
2025/05/01 | 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 | ||
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 |
|---|---|---|---|---|---|
| Durvalumab Injection | 国药准字SJ20190038 | 生物制品 | 注射剂 | 5/23/2024 | |
| Durvalumab Injection | 国药准字SJ20190039 | 生物制品 | 注射剂 | 5/23/2024 |
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 |