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.

health-canada-dpdRegulatory50 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as KEYTRUDA SC (DIN 02565382) under ATC L01FF02 PEMBROLIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 5, 2026	health-canada-dpd
CA

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 17 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 51–55 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
High2
Pembrolizumab	Solid Neoplasm

Clinical trials

Trials with this intervention (2,184)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 2,051–2,100 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
NCT02337491	Pembrolizumab +/- Bevacizumab for Recurrent GBM	completed	Phase 2	80	Dana-Farber Cancer InstituteOTHER	1	Dec 22, 2020	clinicaltrials
NCT02447003	Study of Pembrolizumab (MK-3475) Monotherapy for Metastatic Triple-Negative Breast Cancer (MK-3475-086/KEYNOTE-086)	completed	Phase 2

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 20 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)