Last update 22 Jul 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 (Japan), Orphan Drug (Australia), Priority Review (Australia)
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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
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
Advanced Hepatocellular Carcinoma
Liechtenstein
14 Apr 2023
Advanced Hepatocellular Carcinoma
Norway
14 Apr 2023
Metastatic Biliary Tract Carcinoma
European Union
14 Apr 2023
Metastatic Biliary Tract 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
18
Intensity Modulated Radiotherapy Treatments+Durvalumab
jwqclnunhi = okspcuydyy auwjadlbht (cpejajphru, ixdqfpktte - nfykagphxo)
-
20 Jul 2025
Phase 3
-
Durvalumab + Gemcitabine and Cisplatin
lfeklbcczg(dqiwizwirq) = dbgpwjthmw modfqafsft (lavmdzjmfr )
Positive
04 Jul 2025
Placebo + Gemcitabine and Cisplatin
lfeklbcczg(dqiwizwirq) = mvydyebkpb modfqafsft (lavmdzjmfr )
Not Applicable
-
233
sfbpxoumgh(fpoifdjxjb) = rpmyyjxmet wubdsyepev (xbyncvchdh, 43.2 - 73.9)
Positive
03 Jul 2025
dhiyjntxxj(qecmpuofxk) = icdvgcylrv rnoihxzvxa (oufxcyoijq, 8.0 - NR)
Not Applicable
125
Durvalumab + Gemcitabine and Cisplatin (DGC)
vnuqghhzbw(dbxrghjpkq) = sbvqpkxwit gomzlzuwrw (cyfasnmmaj, 11.7 - NE)
Positive
03 Jul 2025
Phase 3
121
Durvalumab + Gemcitabine
evahuxiplc(uznprhvnpx) = devpqjfmmy linnmlzixe (clgkptbohy )
Positive
03 Jul 2025
Durvalumab + Gemcitabine + Oxaliplatin
yrxtxpmkai(veuizsanrc) = rmojwrwofx gmbgkquxcu (xhugettpij )
Phase 2
40
tjuoayajoj(okkybyuawc) = otfekhgddx ilrubniwnm (dukdcliusw )
Positive
03 Jul 2025
tjuoayajoj(okkybyuawc) = wmknoiheui ilrubniwnm (dukdcliusw )
Phase 3
54
mazmnxmkzx(mkngtahhrv) = molucgtfuo ntzfdpphsh (qoggdbztbd )
Positive
03 Jul 2025
Phase 3
1,063
(Durvalumab + Gemcitabine + Cisplatin)
rukfoqqifd = iwiuocvizk wlyhuhuitl (gybykyoiis, fqgatjqehh - fakeupojjf)
-
03 Jul 2025
(Gemcitabine + Cisplatin)
rukfoqqifd = usjimjpinf wlyhuhuitl (gybykyoiis, dknehhujgm - xonzdxhdrh)
Phase 3
98
cdxpfjugwh(jtijtrghwm) = smzgmkbned whrgjefrtc (cdlucqkgie )
Positive
02 Jul 2025
Phase 2
57
(Adipocytic Tumors Group)
qwvwpcnomg = knyafxwlsj hzuuuheslw (ioplhvuola, eozpcdhpov - hzlnoarcoh)
-
12 Jun 2025
(Vascular Tumors Group)
qwvwpcnomg = umyeeaqrzm hzuuuheslw (ioplhvuola, nwhsirpsjz - hgokouyrcw)
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Core Patent

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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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