Erdafitinib
Balversa (erdafitinib) is a small molecule pharmaceutical. Erdafitinib was first approved as Balversa on 2019-04-12. It is used to treat transitional cell carcinoma in the USA. It is known to target fibroblast growth factor receptor 2, fibroblast growth factor receptor 4, vascular endothelial growth factor receptor 2, fibroblast growth factor receptor 1, and fibroblast growth factor receptor 3.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
Trade Name
FDA
EMA
Balversa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Erdafitinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BALVERSA | Johnson & Johnson | N-212018 RX | 2019-04-12 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| balversa | New Drug Application | 2020-07-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| transitional cell carcinoma | — | D002295 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ERDAFITINIB, BALVERSA, JANSSEN BIOTECH | |||
| 2024-04-12 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | C67 | 3 | 4 | — | — | 1 | 8 | |
| Neoplasms | D009369 | C80 | 2 | 3 | — | — | — | 5 | |
| Urologic neoplasms | D014571 | C64-C68 | 2 | 2 | — | — | 1 | 4 | |
| Multiple myeloma | D009101 | C90.0 | 1 | 3 | — | — | — | 3 | |
| Prostatic neoplasms | D011471 | C61 | — | 3 | — | — | — | 3 | |
| Lymphoma | D008223 | C85.9 | 2 | 1 | — | — | — | 3 | |
| Glioma | D005910 | EFO_0000520 | — | 3 | — | — | — | 3 | |
| Adenocarcinoma | D000230 | 1 | 2 | — | — | — | 3 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Lung neoplasms | D008175 | C34.90 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 7 | — | — | — | — | 7 | ||
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Urethral neoplasms | D014523 | EFO_0003846 | 1 | — | — | — | — | 1 | |
| Ureteral neoplasms | D014516 | EFO_0003844 | C66 | 1 | — | — | — | — | 1 |
| Pelvic neoplasms | D010386 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transitional cell carcinoma | D002295 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ERDAFITINIB |
| INN | erdafitinib |
| Description | Erdafitinib, sold under the brand name Balversa, is an anti-cancer medication. It is a small molecule inhibitor of fibroblast growth factor receptor (FGFR) used for the treatment of cancer. FGFRs are a subset of tyrosine kinases which are unregulated in some tumors and influence tumor cell differentiation, proliferation, angiogenesis, and cell survival. Astex Pharmaceuticals discovered the drug and licensed it to Janssen Pharmaceuticals for further development.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc(OC)cc(N(CCNC(C)C)c2ccc3ncc(-c4cnn(C)c4)nc3c2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1346242-81-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545376 |
| ChEBI ID | — |
| PubChem CID | 67462786 |
| DrugBank | DB12147 |
| UNII ID | 890E37NHMV (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
FGFR2
FGFR2
FGFR4
FGFR4
KDR
KDR
FGFR1
FGFR1
FGFR3
FGFR3
Organism
Homo sapiens
Gene name
FGFR2
Gene synonyms
BEK, KGFR, KSAM
NCBI Gene ID
Protein name
fibroblast growth factor receptor 2
Protein synonyms
bacteria-expressed kinase, BEK fibroblast growth factor receptor, CD332, K-sam, Keratinocyte growth factor receptor, KGFR, protein tyrosine kinase, receptor like 14
Uniprot ID
Mouse ortholog
Fgfr2 (14183)
fibroblast growth factor receptor 2 (P21803)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,166 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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524 adverse events reported
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