Last update 24 May 2025

Cemiplimab-RWLC

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Cemiplimab, cemiplimab, Cemiplimab (Genetical Recombination)(JAN)
+ [5]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (28 Sep 2018),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Australia), Paediatric investigation plan (European Union), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Cemiplimab-RWLC

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic Carcinoma to the Uterine Cervix
European Union
17 May 2023
Metastatic Carcinoma to the Uterine Cervix
Iceland
17 May 2023
Metastatic Carcinoma to the Uterine Cervix
Liechtenstein
17 May 2023
Metastatic Carcinoma to the Uterine Cervix
Norway
17 May 2023
Advanced Cervical Carcinoma
Japan
23 Dec 2022
Recurrent Cervical Cancer
Japan
23 Dec 2022
Uterine Cervical Cancer
Canada
25 Mar 2022
Advanced Skin Squamous Cell Carcinoma
European Union
28 Jun 2019
Advanced Skin Squamous Cell Carcinoma
Iceland
28 Jun 2019
Advanced Skin Squamous Cell Carcinoma
Liechtenstein
28 Jun 2019
Advanced Skin Squamous Cell Carcinoma
Norway
28 Jun 2019
Basal Cell Carcinoma
European Union
28 Jun 2019
Basal Cell Carcinoma
Iceland
28 Jun 2019
Basal Cell Carcinoma
Liechtenstein
28 Jun 2019
Basal Cell Carcinoma
Norway
28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma
European Union
28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma
Iceland
28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma
Liechtenstein
28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma
Norway
28 Jun 2019
Metastatic basal cell carcinoma
European Union
28 Jun 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-small cell lung cancer stage IIIAPhase 3
Austria
01 Sep 2025
Non-small cell lung cancer stage IIIAPhase 3
Estonia
01 Sep 2025
Non-small cell lung cancer stage IIIAPhase 3
France
01 Sep 2025
Non-small cell lung cancer stage IIIAPhase 3
Germany
01 Sep 2025
Non-small cell lung cancer stage IIIAPhase 3
Ireland
01 Sep 2025
Non-small cell lung cancer stage IIIAPhase 3
Italy
01 Sep 2025
Non-small cell lung cancer stage IIIAPhase 3
Singapore
01 Sep 2025
Non-small cell lung cancer stage IIIAPhase 3
Spain
01 Sep 2025
Non-small cell lung cancer stage IIIAPhase 3
Switzerland
01 Sep 2025
Recurrent Non-Small Cell Lung CancerPhase 3
United States
11 Jul 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Phase 3
-
ngxsdqibfg(yargwjimci) = cgulamqyje uqblqwqcau (vymcgjfisd )
Positive
20 May 2025
对照组化疗
ngxsdqibfg(yargwjimci) = bquaydvfep uqblqwqcau (vymcgjfisd )
Phase 1
3
vlwvusnqac(mkheyxrmox) = Two grade 3 treatment-related adverse events were reported: rash zbiyztualk (uuyiwqmmdo )
Negative
28 Apr 2025
Phase 1
20
warllcryrl(nbqhgtvnuz) = dlyuheyigk vpmnuyyttx (offhduvyhq )
Positive
27 Apr 2025
Phase 3
73
cemiplimab IV + chemotherapy
nxgwmcbkwm(ygrcmdoalm) = txvubbqevj ooenzlhrsh (jgxdaikpqu )
Positive
26 Mar 2025
nxgwmcbkwm(ygrcmdoalm) = ztgddccota ooenzlhrsh (jgxdaikpqu )
Not Applicable
PD-L1 positive Non-Small Cell Lung Cancer
First line
PD-L1 expression | KRAS mutations
150
tpjgrhwyoy(gmcofyrhmd) = Immune-related adverse events occurred in 28.7% of pts and led to treatment discontinuation in 13.3% of cases xqnfiwzrsd (bumagtuagq )
-
26 Mar 2025
Phase 2
Interleukin-6
12
aklkehsjdb(asqblltozw) = oqcdnojyob ealdpymjya (jeeikfvphh )
Positive
26 Mar 2025
Phase 3
712
xqznmgmlxi(qsbucomulf) = xmwvggtott iwjcnrhzkx (avlzvoiswl )
Positive
19 Mar 2025
Chemotherapy
xqznmgmlxi(qsbucomulf) = sujpxzmzig iwjcnrhzkx (avlzvoiswl )
Phase 2
29
Cemiplimab + standard of care chemotherapy
xvbdjbqvut(hfgovdfxsf) = oudsebpcfp sxbksypzib (cdvhmjbmsk, 44.4 - 79.7)
Positive
13 Feb 2025
Phase 2
18
mzfyvkqlby(mrrmkcfmap) = nwlqruzjgw lbumghpowi (wyhginfvng, 20.3 - 61.4)
Positive
13 Feb 2025
Phase 3
415
tfqkcgdoks(qxkadqespe): HR = 0.32 (95% CI, 0.20 - 0.51), P-Value = <0.0001
Met
Positive
13 Jan 2025
placebo
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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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