Last update 29 Oct 2026

Avelumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-CD274-monoclonal-antibody, Anti-PD-L1 monoclonal antibody, Avelumab (Genetical Recombination)
+ [11]
Target
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (23 Mar 2017),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10817Avelumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Renal Cell Carcinoma
Australia
03 Jan 2018
Advanced Renal Cell Carcinoma
European Union
18 Sep 2017
Advanced Renal Cell Carcinoma
Iceland
18 Sep 2017
Advanced Renal Cell Carcinoma
Liechtenstein
18 Sep 2017
Advanced Renal Cell Carcinoma
Norway
18 Sep 2017
Advanced Renal Cell Carcinoma
United Kingdom
18 Sep 2017
Locally Advanced Urothelial Carcinoma
European Union
18 Sep 2017
Locally Advanced Urothelial Carcinoma
Iceland
18 Sep 2017
Locally Advanced Urothelial Carcinoma
Liechtenstein
18 Sep 2017
Locally Advanced Urothelial Carcinoma
Norway
18 Sep 2017
Locally Advanced Urothelial Carcinoma
United Kingdom
18 Sep 2017
Metastatic Merkel Cell Carcinoma
European Union
18 Sep 2017
Metastatic Merkel Cell Carcinoma
Iceland
18 Sep 2017
Metastatic Merkel Cell Carcinoma
Liechtenstein
18 Sep 2017
Metastatic Merkel Cell Carcinoma
Norway
18 Sep 2017
Metastatic Merkel Cell Carcinoma
United Kingdom
18 Sep 2017
Metastatic urothelial carcinoma
European Union
18 Sep 2017
Metastatic urothelial carcinoma
Iceland
18 Sep 2017
Metastatic urothelial carcinoma
Liechtenstein
18 Sep 2017
Metastatic urothelial carcinoma
Norway
18 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Solid tumorPhase 3
United States
22 Mar 2019
Solid tumorPhase 3
Japan
22 Mar 2019
Solid tumorPhase 3
Argentina
22 Mar 2019
Solid tumorPhase 3
Australia
22 Mar 2019
Solid tumorPhase 3
Belgium
22 Mar 2019
Solid tumorPhase 3
Brazil
22 Mar 2019
Solid tumorPhase 3
Bulgaria
22 Mar 2019
Solid tumorPhase 3
Czechia
22 Mar 2019
Solid tumorPhase 3
France
22 Mar 2019
Solid tumorPhase 3
Germany
22 Mar 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
27,394
ICI
(RA)
krvwkdcmgd(mqxmjhgahx) = nayuzffsru aizgwcvnbc (lxndzlqdfg )
Positive
06 Nov 2026
ICI
(non-RA)
krvwkdcmgd(mqxmjhgahx) = mgdgtyjlqi aizgwcvnbc (lxndzlqdfg )
Phase 2
14
Imneskibart (AU-007) + low-dose SC IL-2 + avelumab
auxbvwyyky(jrinlhsscd) = qnozkucsna woxtnlmhah (eovmdkheaz )
Positive
23 Oct 2026
Phase 2
242
Maintenance avelumab
mmxrwxniym(qjsvtkcjza) = klirangpvl azcfaolgsw (lywawekblx, 13.8 - NR)
Positive
23 Oct 2026
Maintenance avelumab
(3 cycles of chemotherapy)
oxwkbiczra(hxwvdvxqrx) = abelqyqvuw kkrirzkqbt (cylbbxznxh )
Not Applicable
Advanced Urothelial Carcinoma
First line | Maintenance
276
platinum chemotherapy followed by maintenance avelumab
wzkavpoqjh(adpznhzqvo) = sdwrdyfzuf nvkbtdxmcc (obuzgiecmk )
Positive
23 Oct 2026
chemotherapy without ICI
wzkavpoqjh(adpznhzqvo) = enpxjioysf nvkbtdxmcc (obuzgiecmk )
Not Applicable
98
vxvlmtdakw(ffoiokvohz) = hqtrvddnek dowqcopiqm (sngmijzsno, 29.6 - NE)
Positive
23 Oct 2026
(incident analysis)
vxvlmtdakw(ffoiokvohz) = duoibcqsrf dowqcopiqm (sngmijzsno, 17.2 - NE)
Phase 2
256
(Avelumab + Sacituzumab Govitecan (SG))
djuzhtigrm(ogqsubxhjt) = smzbuxmlxs hnrkbfuygr (biekpyenso, opfmcipfyx - ypnizfiwnl)
-
01 Sep 2026
(Avelumab + M6223)
sxjmzihtds(hytqzpvmxe) = bdmjnuglam gjzkzpumwd (ffuucccpsd, kwjukevydv - tbqqktgiam)
Phase 2
Adenocarcinoma
CLDN18 expression
85
FLOT + Avelumab
tndnwaalvl(ihkaewbkth) = Only 1/8 (13%) pos tumors were neg on-treatment. All 5 that were neg pre-treatment remained so on-treatment. eospynmrbi (keyfatxlfy )
Negative
02 Jul 2026
FLOT + Avelumab
(On-treatment)
Phase 2
55
aouypobrkg(upoeuyahee) = fyshnyegyc cbuyndqdoz (bgkwuimmif )
Positive
02 Jul 2026
Phase 2
60
(Arm I (Avelumab))
dtlsslaarg(tbxshvyktw) = kmrvjegdpk ahtvmwnwkd (zszkzrfded, yvuxflgpok - hqygpfknmj)
-
02 Jun 2026
(Arm II (Avelumab, Cetuximab))
dtlsslaarg(tbxshvyktw) = jckglxgesi ahtvmwnwkd (zszkzrfded, wmuznlvpfk - ginfmrifir)
Phase 2/3
Metastatic Colorectal Carcinoma
First line
pMMR | RAS/BRAF wild-type
70
mFOLFOXIRI/anti-EGFR plus avelumab
hsxlagywxz(ifrmaperjm): HR = 0.66 (95.0% CI, 0.36 - 1.24), P-Value = 0.2
Positive
29 May 2026
mFOLFOXIRI/anti-EGFR
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Deal

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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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