Drug · Monoclonal Antibody

Pembrolizumab

CI-DRUG-00000464Explore in graph →NCIt C106432 CHEMBL3137343 CIViC Approved

Regulatory

Approvals (148)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory48 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2017-05-23 (see label)	approved	May 23, 2017	openfda
US FDA	—	Efficacy supplement 2017-05-18 (see label)	approved	May 18, 2017	openfda

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	969	472	309	2,151	148	CA, EU, US	Sep 4, 2014	Aug 26, 2010
Malignant Lung Neoplasm	Approved	Phase 4	210	103	113	461	6	US	Sep 4, 2014	Apr 26, 2013
Malignant Breast Neoplasm	Approved	Phase 3	112	58	19	221	3	US	Sep 4, 2014	Aug 26, 2010
Malignant Kidney Neoplasm	Approved	Phase 3	51	23	13	112

Curated evidence

Clinical evidence (55)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–50 of 55 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
High4
Ipilimumab + Lenvatinib

Clinical trials

Trials with this intervention (2,184)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 2,001–2,050 of 2,184 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02691026	A Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery	terminated	Phase 2	8	Oslo University HospitalOTHER	1	Jun 23, 2021	clinicaltrials
NCT01840579	Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011)

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Programmed cell death protein 1 inhibitor
Targets: 1 gene
UNII: DPT0O3T46P
Aliases: BCD-201, GME 751, GME751, Immunoglobulin G4, Anti-(Human Programmed Cell Death 1); Humanized Mouse Monoclonal (228-L-proline(H10-S>P))gamma 4 Heavy Chain (134-218')-disulfide With Humanized Mouse Monoclonal Kappa Light Chain Dimer (226-226'':229-229'')-bisdisulfide, Keytruda, KEYTRUDA, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, PEMBROLIZUMAB COMPONENT OF KEYLYNK-010, Pembrolizumab component of mk-1308a, Pembrolizumab component of mk 7684a, QL2107, RPH 075, RPH075, SB 27, SB27, SCH 900475, SCH-900475, SCH900475

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (8)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FF02	PEMBROLIZUMAB
DIN (Health Canada)

ERBB2 Amplification2
Chemotherapy + Pembrolizumab + TrastuzumabCombination	Gastroesophageal Junction Adenocarcinoma	Predictive	A	Supports Sensitivity Response	4	submitted	EID11252 In this randomized, double-blind, placebo-controlled, Phase III trial, 264 patients were enrolled with histologically or cytologically confirmed diagnoses of previously untreated, locally advanced, un… (full text at CIViC) PMID 34912120 · Janjigian et al., 2021 · Open in CIViC	civic
〃	Malignant Gastric Neoplasm	Predictive	A	Supports Sensitivity Response	4	submitted	EID11251 In this randomized, double-blind, placebo-controlled, Phase III trial, 264 patients were enrolled with histologically or cytologically confirmed diagnoses of previously untreated, locally advanced, un… (full text at CIViC) PMID 34912120 · Janjigian et al., 2021 · Open in CIViC	civic

POLE Mutation3
Pembrolizumab	GlioblastomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1861 Case report of a patient with glioblastoma multiforme and POLE germline mutation. The patient was treated with pembrolizumab and lymphocyte infiltration was noted after resection of a spinal metastasi… (full text at CIViC) PMID 27683556 · Johanns et al., 2016 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	submitted	EID7469 In a case report, patient with metastatic colorectal cancer harboring MSS and POLE mutation was treated with pembrolizumab and showed tumor response. PMID 28188185 · Gong et al., 2017 · Open in CIViC	civic
〃	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1862 Case report of a patient with endometrial cancer and exceptional response to pembrolizumab (maintained at 14 months). POLE mutations V411L (exonuclease domain) and R114* were identified in the primary… (full text at CIViC) PMID 27159395 · Mehnert et al., 2016 · Open in CIViC	civic

CD274 Overexpression + MET Exon 14 Skipping MutationCD274 MET3
Pembrolizumab	Lung Adenocarcinoma	Predictive	C	Supports Resistance	3	submitted	EID11396 A 71-year old woman (non-smoker) was diagnosed with poorly differentiated lung adenocarcinoma following immunohistochemistry of tumor cells and biopsy staining. High PD-L1 expression was also confirme… (full text at CIViC) PMID 30600919 · Baba et al., 2019 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	submitted	EID11419 Twenty-four patients with MET exon 14 skipping mutation and PD-L1 expression >50% were included in this retrospective study. Median overall survival of these patients was 12.1 months (CI: 9.1 - NR) an… (full text at CIViC) PMID 36210290 · Guisier et al., 2022 · Open in CIViC	civic
Carboplatin/Pemetrexed Regimen + PembrolizumabCombination	Lung Sarcomatoid Carcinoma	Predictive	C	Supports Sensitivity Response	2	submitted	EID11457 A 65-year old male (non-smoker) presented with advanced sarcomatoid non-small-cell lung cancer harboring a MET exon 14 skipping mutation with elevated PDL1 levels (tumor proportion score of 80%). Afte… (full text at CIViC) PMID 35871685 · Gonugunta et al., 2022 · Open in CIViC	civic

CD274 Expression8
Nivolumab + PembrolizumabSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID743 Based on a meta-analysis of 20 trials (1475 patients), PD-L1 expression was associated with a higher ORR rate in patients with NSCLC. Active drugs were Nivolumab and Pembrolizumab, PD-1 receptor targe… (full text at CIViC) PMID 26086854 · Carbognin et al., 2015 · Open in CIViC	civic
Atezolizumab + Avelumab + Nivolumab + PembrolizumabSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1167 Meta-Analysis of PD-L1 (CD274) Expression Status in 914 patients (7 studies) and response to PD-1/PD-L1 monoclonal antibodies. Patients with PD-L1 positive tumors (PD-L1 tumor cell staining ≥1%), had … (full text at CIViC) PMID 26918451 · Passiglia et al., 2016 · Open in CIViC	civic
Atezolizumab + Avelumab + Durvalumab + Nivolumab + PembrolizumabSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4857 In this meta-analysis of 14 studies with 2857 patients, the immunotherapy response rate was higher among PD-L1-positive patients (RR: 2.19, 95% CI: 1.63-2.94). PD-L1 expression was also related to bet… (full text at CIViC) PMID 28472902 · Aguiar et al., 2017 · Open in CIViC	civic
Pembrolizumab	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1733 This open-label, randomized, phase-3 clinical trial compared pembrolizumab to chemotherapy in treating NSCLC patients with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation o… (full text at CIViC) PMID 27718847 · Reck et al., 2016 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID5811 PD-L1 expression in at least 50% of tumor cells correlated with improved efficacy of pembrolizumab. PMID 25891174 · Garon et al., 2015 · Open in CIViC	civic
Nivolumab + PembrolizumabSubstitutes	Melanoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID704 Based on a meta-analysis of 20 trials (1475 patients), of which 7 studies (636 patients) included melanoma, PD-L1 expression was associated with a higher ORR rate in patients with melanoma. Active dru… (full text at CIViC) PMID 26086854 · Carbognin et al., 2015 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	1	submitted	EID9008 Within a preclinical trial, 37 patients with metastatic melanoma showed a limited number of cases that responded to anti-PD-1 antibodies in correlation to higher immunohistochemical PD-L1 expression. … (full text at CIViC) PMID 27491654 · Cho et al., 2016 · Open in CIViC	civic
Pembrolizumab	Merkel Cell Carcinoma	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID1578 Patients with Merkel Cell Carcinoma (n=26) were enrolled to receive pembrolizumab. Of these patients, 25 were evaluated for response rate to pembrolizumab and PD-L1 (CD274) expression. The response ra… (full text at CIViC) PMID 27093365 · Nghiem et al., 2016 · Open in CIViC	civic