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.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC, or with Stage III melanoma and lymph node involvement who have undergone complete resection. Non small cell lung carcinoma (NSCLC) Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non small cell lung carcinoma at high risk of recurrence in adults Keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5.1). Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. Keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. Keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. Malignant pleural mesothelioma (MPM) Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma. Classical Hodgkin lymphoma (cHL) Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Urothelial carcinoma Keytruda, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy. Keytruda, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy.Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. Head and neck squamous cell carcinoma (HNSCC) Keytruda as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 FU) chemotherapy, is indicated for the first line treatment of metastatic or unresectable …

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 151–200 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
NCT04585750	The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)	recruiting	Phase 1 / Phase 2	300	PMV Pharmaceuticals, IncINDUSTRY	9	Sep 15, 2026	clinicaltrials
NCT05410145	A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation	recruiting

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)