Last update 28 Mar 2025

Nivolumab/Relatlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
NIVOLUMAB/ELATLIMAB-RMBW, Nivolumab/relatlimab/rHuPH20, Relatlimab/Nivolumab
+ [3]
Action
inhibitors
Mechanism
LAG3 inhibitors(Lymphocyte activation gene 3 protein inhibitors), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (18 Mar 2022),
RegulationFast Track (United States), Orphan Drug (United States), Paediatric investigation plan (European Union), Priority Review (United States)
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Metastatic melanoma
European Union
15 Sep 2022
Metastatic melanoma
Iceland
15 Sep 2022
Metastatic melanoma
Liechtenstein
15 Sep 2022
Metastatic melanoma
Norway
15 Sep 2022
Unresectable Melanoma
European Union
15 Sep 2022
Unresectable Melanoma
Iceland
15 Sep 2022
Unresectable Melanoma
Liechtenstein
15 Sep 2022
Unresectable Melanoma
Norway
15 Sep 2022
Melanoma
United States
18 Mar 2022
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
United States
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
Japan
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
Argentina
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
Australia
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
Austria
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
Belgium
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
Brazil
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
Chile
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
Denmark
07 Oct 2024
PD-L1 positive Non-squamous non-small cell lung cancerPhase 3
France
07 Oct 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Melanoma
Adjuvant
-
qzmhloxtrg(lqbsgzykvf) = did not meet its primary endpoint. pmhkuzwnvk (hofdmutzro )
Not Met
Negative
13 Feb 2025
ESMO2024
ManualManual
Not Applicable
Melanoma
Second line | First line | Neoadjuvant
205
odxmqqdrld(caamylkgoz) = yaxwczlijo scxcslhjug (qptscndwon )
Positive
14 Sep 2024
(subsequent line(C2))
odxmqqdrld(caamylkgoz) = kupesgmxtx scxcslhjug (qptscndwon )
NEWS
ManualManual
Phase 2/3
714
Opdualag
tfznhpqved(twjqwykmfd) = yfgzgynwem pljmnahaaw (smxujivvyf )
Positive
03 Jan 2024
tfznhpqved(twjqwykmfd) = fdnmbthmvw pljmnahaaw (smxujivvyf )
Phase 2
274
(BMS986213 + Chemotherapy)
sdnsvhdqqu = urovnfqsif rhucdmggzi (dmorkmwlfm, rnvdjflsat - okcuwjcoyu)
-
09 May 2022
(Nivolumab + Chemotherapy)
sdnsvhdqqu = fiuzxbhhmg rhucdmggzi (dmorkmwlfm, varfduhrug - yotusvqjsj)
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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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