MedPath

Durvalumab

Generic Name
Durvalumab
Brand Names
Imfinzi
Drug Type
Biotech
CAS Number
1428935-60-7
Unique Ingredient Identifier
28X28X9OKV

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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