Last update 21 Nov 2024

Pembrolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (USAN)
+ [10]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (04 Sep 2014),
RegulationConditional marketing approval (CN), PRIME (EU), Orphan Drug (JP), Priority Review (AU), Breakthrough Therapy (US), Accelerated Approval (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Advanced Renal Cell Carcinoma
LI
17 Jul 2015
Advanced Renal Cell Carcinoma
IS
17 Jul 2015
Advanced Renal Cell Carcinoma
NO
17 Jul 2015
Advanced Renal Cell Carcinoma
EU
17 Jul 2015
Gastroesophageal junction adenocarcinoma
IS
17 Jul 2015
Gastroesophageal junction adenocarcinoma
LI
17 Jul 2015
Gastroesophageal junction adenocarcinoma
EU
17 Jul 2015
Gastroesophageal junction adenocarcinoma
NO
17 Jul 2015
HER2 negative Gastroesophageal Junction Adenocarcinoma
LI
17 Jul 2015
HER2 negative Gastroesophageal Junction Adenocarcinoma
NO
17 Jul 2015
HER2 negative Gastroesophageal Junction Adenocarcinoma
IS
17 Jul 2015
HER2 negative Gastroesophageal Junction Adenocarcinoma
EU
17 Jul 2015
Locally Advanced Lung Non-Small Cell Carcinoma
IS
17 Jul 2015
Locally Advanced Lung Non-Small Cell Carcinoma
LI
17 Jul 2015
Locally Advanced Lung Non-Small Cell Carcinoma
NO
17 Jul 2015
Locally Advanced Lung Non-Small Cell Carcinoma
EU
17 Jul 2015
Unresectable Melanoma
EU
17 Jul 2015
Unresectable Melanoma
LI
17 Jul 2015
Unresectable Melanoma
IS
17 Jul 2015
Melanoma
US
04 Sep 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Uterine Cervical CancerNDA/BLA
CN
04 Apr 2024
Transitional Cell CarcinomaNDA/BLA
CN
28 Mar 2024
Recurrent Endometrial CancerNDA/BLA
US
21 Feb 2024
ER-positive/HER2-negative Breast CancerNDA/BLA
CN
08 Nov 2023
Locally Advanced CholangiocarcinomaNDA/BLA
US
08 Jun 2023
Metastatic Biliary Tract CarcinomaNDA/BLA
US
08 Jun 2023
Unresectable Biliary Tract CarcinomaNDA/BLA
US
08 Jun 2023
Small intestine carcinomaNDA/BLA
EU
25 Mar 2022
Stomach CancerNDA/BLA
EU
25 Mar 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
xappkuvyoq(wyqcwlhyzh) = led to discontinuations in 2 patients (at 2 and 6 months) ceohqgysjc (cbckookrqc )
-
08 Dec 2024
Not Applicable
-
Pembrolizumab plus AVD and RT
uziohzfsob(xqwsfsgjmo) = treatment-related adverse events (AEs) were reported in 8 patients (80%); grade 3 or 4 treatment-related AEs occurred in 4 patients (40%). No patients discontinued or died due to treatment-related AEs. Seven patients (67%) had pembrolizumab-related AEs, 3 of whom (30%) had a grade 3 event (vomiting, lymphocyte count decreased, white blood cell count decreased). Immune-mediated AEs occurred in 3 patients (30%; all grade 1 or 2 hypothyroidism) cnybaicbgb (mtyfxtupku )
-
08 Dec 2024
Not Applicable
-
Pembrolizumab plus COPDAC-28 with RT
(fcvfhhakbw) = dupzlxfork pnllhcqcjs (auqyauckqu, 93 - 100)
-
08 Dec 2024
Pembrolizumab plus COPDAC-28 without RT
ygtgudomyj(rjnkrwqzob) = rluqjxiifs uvmvqgxljr (nugpduebmp )
Phase 2
28
hmnhryrcuo(ffmezfgyit) = fvqangqkcn jlhwapknwe (tdhweoavce, onhjytlaiu - yrjdozxosk)
-
15 Nov 2024
Phase 1/2
12
(Cohort 1B: Checkpoint Inhibitor Naïve)
woworgapis(nhawwdgawl) = jegdfdkaoi zyfrrlijtp (yghcbnthqu, azmbikbolf - zmdgvseeuh)
-
14 Nov 2024
(Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure)
woworgapis(nhawwdgawl) = taohgqppbb zyfrrlijtp (yghcbnthqu, waxkyzdqxi - wkvohlyqtq)
Phase 1
35
(Dose Expansion Arm A, Melanoma)
ylcvseihoc(wrdswemjjv) = xinxmfxbuv gudknhryrt (koxtfdbvyf, kijevppnku - dtfnbkssbs)
-
12 Nov 2024
(Dose Expansion Arm B, HNSCC)
ylcvseihoc(wrdswemjjv) = ppcipfrnsk gudknhryrt (koxtfdbvyf, wgnnooqiva - wqqawyzjsw)
Phase 2
17
noayhnzixn(fytcevqkph) = ymdgvnlzil hcciyswynq (azdngqviaj, sonhpyiovc - tdfnpqfeex)
-
07 Nov 2024
Phase 2
243
(euirzossds) = zetpfjruun azancgfiox (bbmrvumygf, 14.5 - 27.3)
Positive
05 Nov 2024
(euirzossds) = rqtovhmwfd azancgfiox (bbmrvumygf, 11.6 - 19.3)
Phase 1
16
(ptkkhmxwpt) = no DLTs were noted in DL 1 (3 mcg/kg) n=3, DL2 (6 mcg/kg) n=2, and DL3 (9 mcg/kg) n=2. One patient experienced a DLT at in DL4 (12 mcg/kg) n=9 and she was able to safely continue treatment. vmfhwendxt (ulqinldzlr )
Positive
05 Nov 2024
Phase 1/2
30
(chmeocifra) = None meffbkrrsg (ltzqogckmj )
Positive
05 Nov 2024
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