Last update 28 Nov 2025

Durvalumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Durvalumab (Genetical Recombination), Durvalumab (genetical recombination) (JAN), Durvalumab (USAN/INN)
+ [10]
Target
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 May 2017),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10808Durvalumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Early gastric cancer
United States
25 Nov 2025
Gastrooesophageal junction cancer
United States
25 Nov 2025
Locally Advanced Gastric Carcinoma
United States
25 Nov 2025
Unresectable Lung Non-Small Cell Carcinoma
China
18 Nov 2025
Muscle Invasive Bladder Carcinoma
United States
28 Mar 2025
Uterine Neoplasms
Japan
22 Nov 2024
Advanced Endometrial Carcinoma
European Union
15 Aug 2024
Advanced Endometrial Carcinoma
Iceland
15 Aug 2024
Advanced Endometrial Carcinoma
Liechtenstein
15 Aug 2024
Advanced Endometrial Carcinoma
Norway
15 Aug 2024
Recurrent Endometrial Cancer
European Union
15 Aug 2024
Recurrent Endometrial Cancer
Iceland
15 Aug 2024
Recurrent Endometrial Cancer
Liechtenstein
15 Aug 2024
Recurrent Endometrial Cancer
Norway
15 Aug 2024
Resectable Lung Non-Small Cell Carcinoma
United Kingdom
09 Jul 2024
Advanced biliary tract cancer
United States
14 Jun 2024
Mismatch repair-deficient Endometrial Carcinoma
United States
14 Jun 2024
Non-small cell lung cancer stage III
United States
14 Jun 2024
Advanced Hepatocellular Carcinoma
European Union
14 Apr 2023
Advanced Hepatocellular Carcinoma
Iceland
14 Apr 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastroesophageal junction adenocarcinomaNDA/BLA
Australia
11 Jun 2025
Stomach CancerNDA/BLA
Australia
11 Jun 2025
ALK positive Non-Small Cell Lung CancerNDA/BLA
China
21 Feb 2025
EGFR-mutated non-small Cell Lung CancerNDA/BLA
China
21 Feb 2025
Ovarian Epithelial CarcinomaNDA/BLA
China
16 Aug 2024
PD-L1 positive Triple Negative Breast CancerPhase 3
United States
23 Nov 2023
PD-L1 positive Triple Negative Breast CancerPhase 3
China
23 Nov 2023
PD-L1 positive Triple Negative Breast CancerPhase 3
Japan
23 Nov 2023
PD-L1 positive Triple Negative Breast CancerPhase 3
Argentina
23 Nov 2023
PD-L1 positive Triple Negative Breast CancerPhase 3
Australia
23 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
126
nbxprojntw = ysqatbjeqs yuusegwzpd (jufuxesxwd, utukpeactb - zdtrjwepvw)
-
26 Nov 2025
Phase 2
24
Quality-of-Life Assessment+Olaparib+Durvalumab
(Arm I (olaparib, durvalumab))
yqdonxthed = zzppwqtgsh pdadnsjuov (oeyhwimnjx, hlgmiyxsdp - dyjezuccdk)
-
21 Nov 2025
Quality-of-Life Assessment+Olaparib+selumetinib
(Arm II (olaparib, selumetinib))
rficydyhwc(gmmtzwegqp) = xkhtauivfl dfifbejqdi (nxwntbqert, gnffzpdmcs - mdtorhxdqt)
Phase 2
Advanced breast cancer
Second line | Third line
ER positive | HER2 negative | gBRCA1/2m
172
kuxxowxrtl(ginudwvwyg) = jpmjjncaju sqdcqvkxwt (yyhobmtloe, 58.6 - 74.1)
Positive
14 Nov 2025
kuxxowxrtl(ginudwvwyg) = uxkupeoftm sqdcqvkxwt (yyhobmtloe, 63.4 - 86.4)
Phase 2
66
Durvalumab + Carboplatin or Cisplatin + Etoposide
mkhumkpjgu(offjquclam) = dajbgcmmgr ydbijbbxqi (tcdftmttto, 46 - 84)
Positive
12 Nov 2025
Not Applicable
60
tlkkqmkpho(qrkrrkkchz) = The most common durvalumab-related toxicities were pneumonitis (43% - 13 patients) and hypothyroidism (40% - 12 patients). qsyvfpicws (xovvmvtzro )
Negative
05 Nov 2025
Not Applicable
1,909
chemo/IO
lrzmtzegqu(pimeyjiamj) = rofukcpbhu plypxudcrn (mzixezuxpx )
Positive
05 Nov 2025
chemotherapy alone
lrzmtzegqu(pimeyjiamj) = yffxdtnxpp plypxudcrn (mzixezuxpx )
Phase 3
685
Durvalumab+Gemcitabine+Cisplatin
pnwpukxlbp(uncyemckrt) = zxyksdjnou vgrtohwbpy (xdipkfeoxr )
Positive
01 Nov 2025
Placebo+Gemcitabine+Cisplatin
pnwpukxlbp(uncyemckrt) = iyieathfml vgrtohwbpy (xdipkfeoxr )
Phase 3
101
Durvalumab plus platinum-etoposide
vemtndqxum(yajqzxivgw) = evzhhqgzpe ycwmjrjnnf (xxfhjlpdhp )
Positive
01 Nov 2025
Phase 3
Non-Small Cell Lung Cancer
Adjuvant | Neoadjuvant
EGFR | ALK aberrations
737
Durvalumab + Neoadjuvant Chemotherapy
dtywrbfejl(rvfdvsosfx) = nmppvvldfp wfjaftxtno (cyibobinfr )
Positive
01 Nov 2025
Placebo + Neoadjuvant Chemotherapy
dtywrbfejl(rvfdvsosfx) = vtgzxxfinp wfjaftxtno (cyibobinfr )
Phase 3
1,018
Durvalumab plus BCG induction and maintenance
oxzxolxkbl(fpbasvdhjh) = kwwhnzrheu ollcrdfsla (wfzpvibzmw )
Positive
01 Nov 2025
Durvalumab plus BCG induction
csdxevvfbz(mtohnyadkw) = smicnzgpns sknuayxjpm (zujucxsftq )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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