Pembrolizumab

Highest phase reached
Drug type
First approval year

First approval year
Listing at source
Listed
Highest phase reached

Drug type
Drug name
Pembrolizumab

  • keytruda
  • Keytruda
  • pembrolizumab component of mk 1308a
  • pembrolizumab component of mk 7684a
  • Pembrolizumab component of mk 7684a
  • Pembrolizumab component of mk-1308a

  • 200 mg pembrolizumab
  • 200 mg Pembrolizumab
  • Drug: Pembrolizumab
  • immunoglobulin g4 anti human protein pdcd1 programmed cell death 1 human mus musculus monoclonal heavy chain disulfide with human mus musculus monoclonal light chain dimer
  • IMMUNOGLOBULIN G4, ANTI-(HUMAN PROTEIN PDCD1 (PROGRAMMED CELL DEATH 1)) (HUMAN-MUS MUSCULUS MONOCLONAL HEAVY CHAIN), DISULFIDE WITH HUMAN-MUS MUSCULUS MONOCLONAL LIGHT CHAIN, DIMER
  • Immunotherapy (pembrolizumab)
  • Immunotherapy (Pembrolizumab)
  • keylynk 010 component pembrolizumab
  • KEYLYNK-010 COMPONENT PEMBROLIZUMAB
  • Keytruda
  • KEYTRUDA ®( Pembrolizumab)
  • keytruda qlex component pembrolizumab
  • KEYTRUDA QLEX COMPONENT PEMBROLIZUMAB
  • Keytruda®
  • KEYTRUDA®
  • Keytruda® (pembrolizumab)
  • KEYTRUDA® (pembrolizumab)
  • KEYTRUDA®, Pembrolizumab
  • Keytruda®(china)
  • lambrolizumab
  • Lambrolizumab
  • MK - 3475
  • mk 1308a component pembrolizumab
  • mk 3475
  • mk 7684a component pembrolizumab

And 72 more, listed on the interactive page.

ATC classification codes
  • L01FF02
Sources for recorded values
CAS registry numbers
  • 1374853-91-4
ChEMBL ID
CHEMBL3137343
RxNorm IDs (RxCUI)
  • 1547545
FDA ingredient codes (UNII)
  • DPT0O3T46P

Applicant
MERCK SHARP DOHME
Approval date
4 Sept 2014
Application number
BLA125514

Status
Authorised
Status date
17 Jul 2015
Authorisation date
17 Jul 2015
Approved indications
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 recurrent head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a CPS ≥ 1. Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a ? 50% TPS and progressing on or after platinum containing chemotherapy. Renal cell carcinoma (RCC) Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5.1). Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers Colorectal cancer (CRC)Keytruda as monotherapy is indicated for theadults with MSI-H or dMMR colorectal cancer in the following settings: first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults; treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy. Non-colorectal cancersKeytruda as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with: advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Oesophageal carcinoma Keytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD L1 with a CPS ≥ 10. Triple negative breast cancer (TNBC) Keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. Keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. Endometrial carcinoma (EC) Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy. Keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. Cervical cancer Keytruda, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy. Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. Gastric or gastro-oesophageal junction (GEJ) adenocarcinoma Keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD L1 with a CPS ≥ 1 (see section 5.1). Biliary tract carcinoma (BTC) Keytruda, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults. Ovarian Cancer Keytruda, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.
Product number
EMEA/H/C/003820
Authorisation holder
Merck Sharp & Dohme B.V.
Priority medicines scheme
No
Generic
No
Biosimilar
No
Generic medicines
0
Biosimilar medicines
0
Advanced therapy
No
Conditional approval
No
Additional monitoring
No
Accelerated assessment
No
Exceptional circumstances
No

Therapeutic areas

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Transitional Cell
  • Endometrial Neoplasms
  • Hodgkin Disease
  • Melanoma
  • Squamous Cell Carcinoma of Head and Neck
  • Urologic Neoplasms
European medicines record

Patents
0
Designations
8
Earliest recorded loss of exclusivity
25 Jan 2031
First in class
Yes
Fast track
No
Breakthrough designation
Yes
Orphan designation
No
Priority review
Yes
Orphan exclusivity
No
Accelerated approval
Yes
Availability
Prescription only

Pharmacology name
pembrolizumab
Type
Antibody
Drug name stem
-mab; -mab
Approval recorded by Guide to Pharmacology
Yes

Administration routes

  • Parenteral

  • Action
    Binding
    Action type
    Binding
    Target
    programmed cell death 1 (CD279)
    Gene symbol
    PDCD1
    Protein identifier
    Q15116
    Median affinity
    10
    Affinity units
    pKd
    Primary target
    Yes
  • Mechanism
    Programmed cell death protein 1 inhibitor
    Action type
    Inhibitor
    Target
    Programmed cell death protein 1
    Protein identifier
    Q15116

Open Targets mechanisms

  • Mechanism
    Programmed cell death protein 1 inhibitor
    Action type
    Inhibitor
    Target
    Programmed cell death protein 1

  • Condition
    Leukemia, Biphenotypic, Acute
    Highest recorded phase
    1
    Condition identifier
    EFO:0000094
    Subject identifier
    D015456
  • Condition
    Leukemia, Lymphocytic, Chronic, B-Cell
    Highest recorded phase
    2
    Condition identifier
    EFO:0000095
    Subject identifier
    D015451
  • Condition
    Lymphoma, Follicular
    Highest recorded phase
    2
    Condition identifier
    EFO:0000096
    Subject identifier
    D008224
  • Condition
    Sarcoma, Ewing
    Highest recorded phase
    1
    Condition identifier
    EFO:0000174
    Subject identifier
    D012512
  • Condition
    Squamous Cell Carcinoma of Head and Neck
    Highest recorded phase
    4
    Condition identifier
    EFO:0000181
    Subject identifier
    D000077195
  • Condition
    Carcinoma, Squamous Cell
    Highest recorded phase
    4
    Condition identifier
    EFO:0000181
    Subject identifier
    D002294
  • Condition
    Carcinoma, Hepatocellular
    Highest recorded phase
    3
    Condition identifier
    EFO:0000182
    Subject identifier
    D006528
  • Condition
    Hodgkin Disease
    Highest recorded phase
    4
    Condition identifier
    EFO:0000183
    Subject identifier
    D006689
  • Condition
    Prostatic Neoplasms
    Highest recorded phase
    3
    Condition identifier
    EFO:0000196
    Subject identifier
    D011471
  • Condition
    Myelodysplastic Syndromes
    Highest recorded phase
    2
    Condition identifier
    EFO:0000198
    Subject identifier
    D009190
  • Condition
    Lymphoma, T-Cell, Peripheral
    Highest recorded phase
    2
    Condition identifier
    EFO:0000211
    Subject identifier
    D016411
  • Condition
    Leukemia, Myeloid, Acute
    Highest recorded phase
    2
    Condition identifier
    EFO:0000222
    Subject identifier
    D015470
  • Condition
    Adenocarcinoma
    Highest recorded phase
    2
    Condition identifier
    EFO:0000228
    Subject identifier
    D000230
  • Condition
    Carcinoma, Adenoid Cystic
    Highest recorded phase
    2
    Condition identifier
    EFO:0000231
    Subject identifier
    D003528
  • Condition
    Astrocytoma
    Highest recorded phase
    1
    Condition identifier
    EFO:0000272
    Subject identifier
    D001254
  • Condition
    Urinary Bladder Neoplasms
    Highest recorded phase
    3
    Condition identifier
    EFO:0000294
    Subject identifier
    D001749
  • Condition
    Breast Neoplasms
    Highest recorded phase
    3
    Condition identifier
    EFO:0000305
    Subject identifier
    D001943
  • Condition
    Carcinoma
    Highest recorded phase
    3
    Condition identifier
    EFO:0000313
    Subject identifier
    D002277
  • Condition
    Carcinoma, Renal Cell
    Highest recorded phase
    4
    Condition identifier
    EFO:0000349
    Subject identifier
    D002292
  • Condition
    Colorectal Neoplasms
    Highest recorded phase
    3
    Condition identifier
    EFO:0000365
    Subject identifier
    D015179
  • Condition
    Melanoma
    Highest recorded phase
    4
    Condition identifier
    EFO:0000389
    Subject identifier
    D008545
  • Condition
    Lymphoma, Large B-Cell, Diffuse
    Highest recorded phase
    2
    Condition identifier
    EFO:0000403
    Subject identifier
    D016403
  • Condition
    Carcinoma, Intraductal, Noninfiltrating
    Highest recorded phase
    0.5
    Condition identifier
    EFO:0000432
    Subject identifier
    D002285
  • Condition
    Adenocarcinoma, Follicular
    Highest recorded phase
    2
    Condition identifier
    EFO:0000501
    Subject identifier
    D018263
  • Condition
    Stomach Neoplasms
    Highest recorded phase
    3
    Condition identifier
    EFO:0000503
    Subject identifier
    D013274

And 174 more, listed on the interactive page.

  • Condition identifier
    EFO_0000095
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000096
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000181
  • Condition identifier
    EFO_0000182
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000183
  • Condition identifier
    EFO_0000196
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000198
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000199
  • Condition identifier
    EFO_0000211
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000222
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000228
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000231
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000272
  • Condition identifier
    EFO_0000294
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000305
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000313
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000365
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000389
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000403
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000432
  • Condition identifier
    EFO_0000503
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000519
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000558
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000571
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000574
    Highest recorded phase
    2

And 360 more, listed on the interactive page.

  • Event
    adrenal insufficiency
    Reports
    698
    Reporting signal score
    1,408.16
  • Event
    autoimmune colitis
    Reports
    195
    Reporting signal score
    660.103
  • Event
    colitis
    Reports
    1,461
    Reporting signal score
    2,493.36
  • Event
    fulminant type 1 diabetes mellitus
    Reports
    237
    Reporting signal score
    794.691
  • Event
    hepatitis
    Reports
    608
    Reporting signal score
    619.024
  • Event
    hyperthyroidism
    Reports
    547
    Reporting signal score
    871.829
  • Event
    hypophysitis
    Reports
    561
    Reporting signal score
    1,772.82
  • Event
    hypothyroidism
    Reports
    1,081
    Reporting signal score
    1,839.92
  • Event
    immune-mediated adverse reaction
    Reports
    305
    Reporting signal score
    1,052.84
  • Event
    immune-mediated enterocolitis
    Reports
    459
    Reporting signal score
    1,603.11
  • Event
    immune-mediated hepatitis
    Reports
    267
    Reporting signal score
    882.152
  • Event
    immune-mediated hypothyroidism
    Reports
    48
    Reporting signal score
    210.5
  • Event
    immune-mediated myocarditis
    Reports
    60
    Reporting signal score
    242.625
  • Event
    immune-mediated pneumonitis
    Reports
    65
    Reporting signal score
    264.736
  • Event
    injection site pain
    Reports
    4
    Reporting signal score
    549.567
  • Event
    interstitial lung disease
    Reports
    277
    Reporting signal score
    233.16
  • Event
    malignant neoplasm progression
    Reports
    2,830
    Reporting signal score
    5,076.76
  • Event
    myasthenia gravis
    Reports
    291
    Reporting signal score
    606.783
  • Event
    myocarditis
    Reports
    449
    Reporting signal score
    767.5
  • Event
    nephritis
    Reports
    105
    Reporting signal score
    250.77
  • Event
    pemphigoid
    Reports
    428
    Reporting signal score
    768.134
  • Event
    pneumonitis
    Reports
    1,318
    Reporting signal score
    2,439.17
  • Event
    therapy partial responder
    Reports
    116
    Reporting signal score
    212.892
  • Event
    thyroiditis
    Reports
    330
    Reporting signal score
    803.585
  • Event
    tubulointerstitial nephritis
    Reports
    479
    Reporting signal score
    590.28

And 3 more, listed on the interactive page.

And 1,363 more, listed on the interactive page.

Dose
200 mg or 400 mg
Route
Intravenous
How often
Every 3 weeks or every 6 weeks

Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Natural product
No

  • Component
    Heavy chain
    Type
    Protein
    Sequence
    QVQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNFNEKFKNRVTLTTDSSTTTAYMELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
  • Component
    Light chain
    Type
    Protein
    Sequence
    EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLESGVPARFSGSGSGTDFTLTISSLEPEDFAVYYCQHSRDLPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

  • 0006-3026
  • 0006-3083
  • 0006-5083

Related records

Trials (2,527)

Approved for (24)

In development for (180)

Other linked conditions (1)

Targets (1)