Imfinzi(durvalumab)
Imfinzi (durvalumab) is an antibody pharmaceutical. Durvalumab was first approved as Imfinzi on 2017-05-01. It is used to treat transitional cell carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against programmed cell death 1 ligand 1.
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Commercial
Trade Name
FDA
EMA
Imfinzi
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)
Durvalumab
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Imfinzi | durvalumab | AstraZeneca UK Ltd | N-761069 RX | 2017-05-01 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
imfinzi | Biologic Licensing Application | 2021-02-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
transitional cell carcinoma | — | D002295 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
durvalumab, Imfinzi, AstraZeneca UK Ltd | |||
2029-10-21 | Orphan excl. |
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
J9173 | Injection, durvalumab, 10 mg |
Clinical
Clinical Trials
620 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Non-small-cell lung carcinoma | D002289 | 33 | 90 | 31 | 1 | 3 | 146 | ||
Neoplasms | D009369 | C80 | 38 | 26 | — | 1 | — | 52 | |
Neoplasm metastasis | D009362 | EFO_0009708 | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lung neoplasms | D008175 | C34.90 | 12 | 34 | 3 | — | 2 | 44 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 22 | 29 | 1 | — | 1 | 42 |
Squamous cell carcinoma of head and neck | D000077195 | 17 | 20 | 3 | — | — | 33 | ||
Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 8 | 20 | 5 | — | 2 | 31 |
Small cell lung carcinoma | D055752 | 6 | 16 | 4 | — | 3 | 28 | ||
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 15 | 18 | 1 | — | — | 26 |
Urinary bladder neoplasms | D001749 | C67 | 9 | 18 | 2 | — | — | 25 | |
Renal cell carcinoma | D002292 | 7 | 12 | 2 | — | — | 18 | ||
Biliary tract neoplasms | D001661 | C24.9 | 3 | 11 | 1 | — | — | 13 | |
Urologic neoplasms | D014571 | C64-C68 | 3 | 8 | 2 | — | — | 11 |
Show 11 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Colorectal neoplasms | D015179 | 17 | 26 | — | — | — | 34 | ||
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 17 | 23 | — | — | — | 32 |
Triple negative breast neoplasms | D064726 | 10 | 13 | — | — | — | 20 | ||
Head and neck neoplasms | D006258 | 11 | 11 | — | — | — | 14 | ||
Melanoma | D008545 | 9 | 6 | — | — | 1 | 13 | ||
Stomach neoplasms | D013274 | EFO_0003897 | C16 | 6 | 11 | — | — | — | 13 |
Cholangiocarcinoma | D018281 | C22.1 | 2 | 11 | — | — | — | 13 | |
Prostatic neoplasms | D011471 | C61 | 4 | 9 | — | — | — | 11 | |
Uterine cervical neoplasms | D002583 | 7 | 7 | — | — | — | 11 | ||
Esophageal neoplasms | D004938 | C15 | 4 | 9 | — | — | — | 10 |
Show 71 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Primary myelofibrosis | D055728 | D47.4 | 2 | — | — | — | — | 2 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 | |
Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
Hodgkin disease | D006689 | C81 | 1 | — | — | — | — | 1 | |
Leukemia myeloid chronic atypical bcr-abl negative | D054438 | C92.2 | 1 | — | — | — | — | 1 | |
Myeloid leukemia chronic-phase | D015466 | 1 | — | — | — | — | 1 | ||
Thrombocytosis | D013922 | D75.83 | 1 | — | — | — | — | 1 | |
Polycythemia | D011086 | EFO_0005804 | D75.1 | 1 | — | — | — | — | 1 |
Show 12 more
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | DURVALUMAB |
INN | durvalumab |
Description | Durvalumab (human mab) |
Classification | Antibody |
Drug class | monoclonal antibodies |
Image (chem structure or protein) | ![]() |
Structure (InChI/SMILES or Protein Sequence) | >5X8M:B|durvalumab heavy chain
EVQLVESGGGLVQPGGSLRLSCAASGFTFSRYWMSWVRQAPGKGLEWVANIKQDGSEKYYVDSVKGRFTISRDNAKNSLY
LQMNSLRAEDTAVYYCAREGGWFGELAFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV
SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTHHHHHH
>5X8M:C|durvalumab light chain
EIVLTQSPGTLSLSPGERATLSCRASQRVSSSYLAWYQQKPGQAPRLLIYDASSRATGIPDRFSGSGSGTDFTLTISRLE
PEDFAVYYCQQYGSLPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS
QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
PDB | 5X8M, 5XJ4 |
CAS-ID | 1428935-60-7 |
RxCUI | 1919503 |
ChEMBL ID | CHEMBL3301587 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB11714 |
UNII ID | 28X28X9OKV (ChemIDplus, GSRS) |
Target
Agency Approved
CD274
CD274
Alternate
No data
Variants
Clinical Variant
No data
Financial
Imfinzi - AstraZeneca
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,280 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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71,483 adverse events reported
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