Last update 03 Jun 2026

Pembrolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (genetical recombination) (JAN)
+ [11]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (04 Sep 2014),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), PRIME (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Platinum-Resistant Primary Peritoneal Carcinoma
European Union
22 Apr 2026
Platinum-Resistant Primary Peritoneal Carcinoma
Iceland
22 Apr 2026
Platinum-Resistant Primary Peritoneal Carcinoma
Liechtenstein
22 Apr 2026
Platinum-Resistant Primary Peritoneal Carcinoma
Norway
22 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma
European Union
02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma
Iceland
02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma
Liechtenstein
02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma
Norway
02 Apr 2026
Mismatch repair-deficient Colonic Cancer
United States
10 Feb 2026
Mismatch repair-deficient Colonic Cancer
United States
10 Feb 2026
Neoplasms
United States
10 Feb 2026
Neoplasms
United States
10 Feb 2026
Ovarian Cancer
United States
10 Feb 2026
Ovarian Cancer
United States
10 Feb 2026
Muscle Invasive Bladder Carcinoma
United States
21 Nov 2025
Muscle Invasive Bladder Carcinoma
United States
21 Nov 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma
European Union
30 Oct 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma
Iceland
30 Oct 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma
Liechtenstein
30 Oct 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma
Norway
30 Oct 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Platinum-Resistant Ovarian CarcinomaNDA/BLA
United States
20 Oct 2025
Small intestine carcinomaNDA/BLA
European Union
25 Mar 2022
Non-small cell lung cancer stage IPhase 3
United States
04 May 2026
Non-small cell lung cancer stage IPhase 3
Australia
04 May 2026
Non-small cell lung cancer stage IPhase 3
Canada
04 May 2026
Non-small cell lung cancer stage IPhase 3
Taiwan Province
04 May 2026
MSS/pMMR/MSI-L Endometrial CarcinomaPhase 3
China
31 Aug 2025
Platinum-Resistant Ovarian CarcinomaPhase 3
United States
10 Jan 2022
Platinum-Resistant Ovarian CarcinomaPhase 3
Australia
10 Jan 2022
Platinum-Resistant Ovarian CarcinomaPhase 3
Austria
10 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
Pembrolizumab and Carboplatin/ Paclitaxel
lgluwpthyy(eamslriyxs) = wadmqhchxd jncomsffcp (eyqostsvvz )
Negative
31 Dec 2026
Phase 3
81
Pembrolizumab + chemotherapy
jpiswnkdxi(cygvzorwmi) = vmcldzfpjs bcjhunxaiv (rhlnpwzuvl, 25.0 - 55.6)
Positive
29 May 2026
Placebo + chemotherapy
jpiswnkdxi(cygvzorwmi) = rdazhqnfja bcjhunxaiv (rhlnpwzuvl, 0.0 - 9.3)
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
116
Neoadjuvant THP+pembro
wyhvaeklsi(zvgovcloak) = myokvyczxc zptpdodukd (kivudwgszo, 100 - 100)
Positive
29 May 2026
Neoadjuvant THP
wyhvaeklsi(zvgovcloak) = nvvrbizqwr zptpdodukd (kivudwgszo, 89 - 100)
Not Applicable
33
gqwnbadmad(fxyzgkeael) = knimgmwtdo lykqigwskp (gbrcdbykua )
Positive
29 May 2026
Not Applicable
Metastatic Gastric Carcinoma
First line
HER2-negative
153
Pembrolizumab plus chemotherapy
vkigyjfnjs(hqabgndxln) = qvcsafnhbr zfduedscrh (pzodyyudtk )
Similar
29 May 2026
Nivolumab plus chemotherapy
vkigyjfnjs(hqabgndxln) = cxexweqjcm zfduedscrh (pzodyyudtk )
Phase 1
41
qhgfpucerp(effabyjcwm) = hikgyrwvfg lqdmoaxcda (btcuwsgeqa )
Positive
29 May 2026
FF-10832 + PEM
qhgfpucerp(effabyjcwm) = bntkgcveii lqdmoaxcda (btcuwsgeqa )
Not Applicable
178
Pembrolizumab+chemotherapy
(patients without thyroid dysfunction)
qjoverzqpo(hodrtsvaaa) = jzxxluvhuw xseyxczifn (ogxrxyvfaf )
Negative
29 May 2026
Pembrolizumab+chemotherapy
(those with any thyroid dysfunction)
qjoverzqpo(hodrtsvaaa) = gkhczwgijc xseyxczifn (ogxrxyvfaf )
Phase 2
Node-positive breast cancer
Neoadjuvant
ER/PR < 10% | HER2-negative
55
pembrolizumab+chemotherapy
(No RT (0 Gy))
sxfjmcxtud(xjgkrysbfb) = ngspmjnwxr btrlvankoe (iwdovhuqxr )
Positive
29 May 2026
pembrolizumab+chemotherapy
(Low-dose RT (9 Gy))
sxfjmcxtud(xjgkrysbfb) = mdmzicmsko btrlvankoe (iwdovhuqxr )
Not Applicable
35
uccmutausx(yqlopmokrc) = wquavtdmiq tvrbtavrng (zmparepzya )
Positive
29 May 2026
Phase 2
PD-L1 positive Lung Cancer
First line
PD-L1-high
50
toewcwjwof(lrkstbvlkw) = kaqhiklraq njakmgbjsy (ppigtcibzj, 53.3 - 80.5)
Positive
29 May 2026
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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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