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Jemperli(dostarlimab)
Jemperli (dostarlimab) is an antibody pharmaceutical. Dostarlimab was first approved as Jemperli on 2021-04-21. It has been approved in Europe to treat endometrial neoplasms. It is known to target programmed cell death protein 1.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Jemperli
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Dostarlimab
Tradename
Proper name
Company
Number
Date
Products
Jemperlidostarlimab-gxlyGSKN-761174 RX2021-04-22
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
jemperliBiologic Licensing Application2021-08-17
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors
— L01FF07: Dostarlimab
HCPCS
Code
Description
J9272
Injection, dostarlimab-gxly, 10 mg
Clinical
Clinical Trials
62 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C801171——17
Ovarian neoplasmsD010051EFO_0003893C56243——8
Endometrial neoplasmsD016889EFO_0004230231—16
Non-small-cell lung carcinomaD002289131——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5013———4
Triple negative breast neoplasmsD064726—3———3
Head and neck neoplasmsD00625813———3
Lung neoplasmsD008175C34.9013———3
Pancreatic neoplasmsD010190EFO_0003860C2512———3
Fallopian tube neoplasmsD00518512———3
Renal cell carcinomaD002292—2———2
Uterine cervical neoplasmsD002583—2———2
Pancreatic ductal carcinomaD021441—2———2
MelanomaD00854512———2
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Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDOSTARLIMAB
INNdostarlimab
Description
Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer. Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)DOSTARLIMAB
Structure (InChI/SMILES or Protein Sequence)
>7WSL:H|heavy chain EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYDMSWVRQAPGKGLEWVSTISGGGSYTYYQDSVKGRFTISRDNSKNTLY LQMNSLRAEDTAVYYCASPYYAMDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSG ALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHHHHHH >7WSL:L|light chain DIQLTQSPSFLSAYVGDRVTITCKASQDVGTAVAWYQQKPGKAPKLLIYWASTLHTGVPSRFSGSGSGTEFTLTISSLQP EDFATYYCQHYSSYPWTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB7WSL
CAS-ID2022215-59-2
RxCUI—
ChEMBL IDCHEMBL4298124
ChEBI ID—
PubChem CID—
DrugBankDB15627
UNII IDP0GVQ9A4S5 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PDCD1
PDCD1
Organism
Homo sapiens
Gene name
PDCD1
Gene synonyms
PD1
NCBI Gene ID
5133
Protein name
programmed cell death protein 1
Protein synonyms
CD279, programmed cell death 1 protein, protein PD-1, systemic lupus erythematosus susceptibility 2
Uniprot ID
Q8IX89
Mouse ortholog
Pdcd1 (18566)
programmed cell death protein 1 (Q02242)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 661 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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7 adverse events reported
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