Tykerb, Tyverb(lapatinib)
Tykerb, Tyverb (lapatinib) is a small molecule pharmaceutical. Lapatinib was first approved as Tykerb on 2007-03-13. It is used to treat breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms. The pharmaceutical is active against epidermal growth factor receptor and receptor tyrosine-protein kinase erbB-2.
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Novartis Pharmaceuticals
Requested
Commercial
Trade Name
FDA
EMA
Tykerb (generic drugs available since 2020-09-29)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lapatinib ditosylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TYKERB | Novartis | N-022059 RX | 2007-03-13 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tykerb | New Drug Application | 2021-02-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Lapatinib Ditosylate, Tykerb, Novartis | |||
| 8821927 | 2029-09-18 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
282 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 56 | 97 | 27 | — | 5 | 170 |
| Head and neck neoplasms | D006258 | 2 | 6 | 1 | — | — | 8 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 4 | 1 | — | — | 7 |
| Male breast neoplasms | D018567 | 3 | 4 | 1 | — | — | 7 | ||
| Urinary bladder neoplasms | D001749 | C67 | 3 | 3 | 1 | — | — | 6 | |
| Gastrointestinal neoplasms | D005770 | C26.9 | — | 2 | 2 | — | — | 4 | |
| Breast diseases | D001941 | N60-N65 | — | 2 | 1 | — | — | 2 | |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | 1 | 2 | ||
| Sarcoma | D012509 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | 3 | 4 | — | — | 2 | 8 | ||
| Squamous cell carcinoma of head and neck | D000077195 | — | 5 | — | — | — | 5 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 2 | — | — | — | 5 |
| Prostatic neoplasms | D011471 | C61 | 2 | 4 | — | — | — | 5 | |
| Non-small-cell lung carcinoma | D002289 | 1 | 3 | — | — | — | 4 | ||
| Adenocarcinoma | D000230 | 2 | 3 | — | — | — | 4 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | 2 | — | — | — | 4 |
| Squamous cell carcinoma | D002294 | — | 4 | — | — | — | 4 | ||
| Neoplasm metastasis | D009362 | EFO_0009708 | 2 | 2 | — | — | 1 | 4 | |
| Glioblastoma | D005909 | EFO_0000515 | 2 | 3 | — | — | — | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | C34.90 | 2 | — | — | — | — | 2 | |
| Renal cell carcinoma | D002292 | 2 | — | — | — | — | 2 | ||
| Thyroid neoplasms | D013964 | EFO_0003841 | 1 | — | — | — | — | 1 | |
| Lymphoma | D008223 | C85.9 | 1 | — | — | — | — | 1 | |
| Chronic renal insufficiency | D051436 | N18 | 1 | — | — | — | — | 1 | |
| Glandular and epithelial neoplasms | D009375 | 1 | — | — | — | — | 1 | ||
| Cystectomy | D015653 | 1 | — | — | — | — | 1 | ||
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | LAPATINIB |
| INN | lapatinib |
| Description | Lapatinib is an organofluorine compound, an organochlorine compound, a member of quinazolines and a member of furans. It has a role as an antineoplastic agent and a tyrosine kinase inhibitor. It is functionally related to a monofluorobenzene. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CS(=O)(=O)CCNCc1ccc(-c2ccc3ncnc(Nc4ccc(OCc5cccc(F)c5)c(Cl)c4)c3c2)o1 |
Target
Agency Approved
EGFR
EGFR
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
Protein name
epidermal growth factor receptor
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b) oncogene homolog, cell growth inhibiting protein 40, cell proliferation-inducing protein 61, EGFR vIII, epidermal growth factor receptor tyrosine kinase domain, erb-b2 receptor tyrosine kinase 1, Proto-oncogene c-ErbB-1, Receptor tyrosine-protein kinase erbB-1
Uniprot ID
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 17,831 documents
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Safety
Black-box Warning
Black-box warning for: Tykerb
Adverse Events
Top Adverse Reactions
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1,382 adverse events reported
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