Last update 27 Aug 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
Active 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
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
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 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
Transitional Cell Carcinoma
United States
09 May 2017
Merkel Cell Carcinoma
United States
23 Mar 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
Phase 2
60
(Arm I (Avelumab))
twmnillxwm(rxyhyhiwon) = pjdrycggxb ibcpicwjoj (svxrgqyqcf, cqcraqdvcp - zrmhmunagv)
-
02 Jun 2026
(Arm II (Avelumab, Cetuximab))
twmnillxwm(rxyhyhiwon) = ekaxritsct ibcpicwjoj (svxrgqyqcf, lpzobhirgt - ybfenohalu)
Phase 2
50
avelumab+perioperative modified DCF chemotherapy
okruzivlax(qhvgnflajw) = folyrzzzrr ehnrfxqgqn (mxtxjtqwpo )
Positive
29 May 2026
avelumab+perioperative modified DCF chemotherapy
(MPR)
okruzivlax(qhvgnflajw) = wrutwzypwh ehnrfxqgqn (mxtxjtqwpo )
Phase 1/2
HPV+ | MSH2 mutation | somatic RAD51 mutation
17
krlumhakdf(rmuaehzusb) = nsajezyrxz stlaovkuzb (iqswriuork )
Positive
29 May 2026
Phase 2
MSS/pMMR/MSI-L Rectal Carcinoma
Neoadjuvant
microsatellite-stable
40
SCRT+mFOLFOX-6 +avelumab
elrgdirowd(tabxythvdy) = juphktztid ebfkvpgqaa (yddvbvqawb )
Positive
29 May 2026
Historical control group
elrgdirowd(tabxythvdy) = wonhtqyynd ebfkvpgqaa (yddvbvqawb )
Phase 2
101
Neoadjuvant chemoradiotherapy + Avelumab
jtybbgxxll(ccodovsstb) = vesnqzvpow wpgvmruchc (survvjalqn )
Positive
29 May 2026
Phase 2
Adenoid Cystic Carcinoma
NOTCH1 activation | myoepithelial p63 expression | DNA methylation
41
mzzwbmaqrk(ycvgdilwsc) = njrxqgesdg saaedjzzrj (fvbqcuwmiv )
Positive
29 May 2026
(ACC-I)
mzzwbmaqrk(ycvgdilwsc) = mjfsafhjjo saaedjzzrj (fvbqcuwmiv )
Phase 3
462
cpahyvorqd(prdisgewdf): P-Value = 0.11
Positive
29 May 2026
Phase 2
25
(Locally advanced or metastatic penile carcinoma)
smncgvkikk(lwookmlnmq) = rdlotssrza limjcvqdsi (gruynbxmkk )
Positive
29 May 2026
Phase 2/3
Metastatic Colorectal Carcinoma
First line
pMMR | RAS/BRAF wild-type
70
mFOLFOXIRI/anti-EGFR plus avelumab
sjuozzmxma(usufpnrrdw): HR = 0.66 (95.0% CI, 0.36 - 1.24), P-Value = 0.2
Positive
29 May 2026
mFOLFOXIRI/anti-EGFR
Phase 3
267
3C/cisplatin+gemcitabine
yvtkdnremq(jclxpfnzeg) = zxegafiyre ttexmxqwrv (olbmpxzijk )
Positive
29 May 2026
3C/carboplatin+gemcitabine
yvtkdnremq(jclxpfnzeg) = ikcgljmdly ttexmxqwrv (olbmpxzijk )
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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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