Durvalumab

Generic Name
Durvalumab
Brand Names
Imfinzi
Drug Type
Biotech
Chemical Formula
-
CAS Number
1428935-60-7
Unique Ingredient Identifier
28X28X9OKV
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)
Associated Therapies
First Line Chemotherapy

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

First Posted Date
2019-01-11
Last Posted Date
2024-08-22
Lead Sponsor
AstraZeneca
Target Recruit Count
826
Registration Number
NCT03800134
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

First Posted Date
2019-01-07
Last Posted Date
2022-02-24
Lead Sponsor
MedImmune LLC
Target Recruit Count
84
Registration Number
NCT03794544
Locations
🇨🇭

Research Site, Zurich, Switzerland

Durvalumab With or Without Tremelimumab in Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity

First Posted Date
2018-12-21
Last Posted Date
2024-07-03
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
21
Registration Number
NCT03784066
Locations
🇧🇪

UZ Leuven, Leuven, Belgium

A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

First Posted Date
2018-12-19
Last Posted Date
2024-11-29
Lead Sponsor
AstraZeneca
Target Recruit Count
724
Registration Number
NCT03778957
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer

First Posted Date
2018-12-17
Last Posted Date
2024-09-30
Lead Sponsor
UNICANCER
Target Recruit Count
112
Registration Number
NCT03777813
Locations
🇫🇷

Centre Oscar Lambret, CLCC UNICANCER, Lille, France

🇫🇷

Hôpital Saint Louis, APHP, Paris, France

🇫🇷

Hôpital Haut-Lévêque, Pessac, France

and more 4 locations

A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)

First Posted Date
2018-12-12
Last Posted Date
2022-09-13
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
12
Registration Number
NCT03773666
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

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