Last update 31 May 2024

Nivolumab/Relatlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
NIVOLUMAB/ELATLIMAB-RMBW, Relatlimab/Nivolumab, BMS-936558/BMS-986016
+ [2]
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
US (18 Mar 2022),
RegulationPriority Review (US), Fast Track (US), Orphan Drug (US), Paediatric investigation plan (EU)
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Unresectable Melanoma
EU
15 Sep 2022
Unresectable Melanoma
IS
15 Sep 2022
Unresectable Melanoma
LI
15 Sep 2022
Unresectable Melanoma
NO
15 Sep 2022
Melanoma
US
18 Mar 2022
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Colorectal CarcinomaPhase 3
US
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
JP
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
AR
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
AU
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
AT
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
BE
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
CA
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
CL
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
CZ
28 Apr 2022
Metastatic Colorectal CarcinomaPhase 3
FR
28 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Phase 2/3
714
Opdualag
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Positive
03 Jan 2024
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Approval

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Regulation

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