Tarceva(erlotinib)
Tarceva (erlotinib) is a small molecule pharmaceutical. Erlotinib was first approved as Tarceva on 2004-11-18. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma and pancreatic neoplasms. The pharmaceutical is active against epidermal growth factor receptor. In addition, it is known to target solute carrier organic anion transporter family member 2B1.
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Commercial
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Erlotinib hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TARCEVA | OSI Pharmaceuticals | N-021743 DISCN | 2004-11-18 | 3 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| erlotinib hydrochloride | ANDA | 2023-02-17 |
| tarceva | New Drug Application | 2018-12-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
724 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 | 75 | 174 | 56 | 11 | 17 | 302 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 27 | 46 | 6 | 1 | 3 | 76 |
| Lung neoplasms | D008175 | C34.90 | 22 | 55 | 6 | 1 | 2 | 74 | |
| Adenocarcinoma of lung | D000077192 | 4 | 9 | — | 1 | 1 | 12 | ||
| Renal cell carcinoma | D002292 | 4 | 8 | — | 1 | 1 | 11 | ||
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 54 | 26 | 3 | — | 4 | 81 | |
| Head and neck neoplasms | D006258 | 13 | 13 | 2 | — | 1 | 25 | ||
| Squamous cell carcinoma | D002294 | 11 | 11 | 1 | — | 2 | 19 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 9 | 12 | 1 | — | 1 | 18 |
| Colorectal neoplasms | D015179 | 5 | 11 | 3 | — | — | 17 | ||
| Squamous cell carcinoma of head and neck | D000077195 | 9 | 10 | 1 | — | — | 16 | ||
| Squamous cell neoplasms | D018307 | 3 | 8 | 3 | — | 1 | 13 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 4 | 10 | 1 | — | — | 12 |
| Esophageal neoplasms | D004938 | C15 | 4 | 7 | 1 | — | — | 12 | |
| Neoplasm metastasis | D009362 | EFO_0009708 | 1 | 4 | 1 | — | 1 | 7 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 8 | 17 | — | — | 1 | 24 |
| Glioblastoma | D005909 | EFO_0000515 | 8 | 12 | — | — | — | 15 | |
| Gliosarcoma | D018316 | 6 | 9 | — | — | — | 12 | ||
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 6 | 4 | — | — | — | 8 |
| Rectal neoplasms | D012004 | 6 | 4 | — | — | — | 8 | ||
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 3 | 5 | — | — | — | 8 |
| Prostatic neoplasms | D011471 | C61 | 3 | 5 | — | — | — | 7 | |
| Central nervous system neoplasms | D016543 | 4 | 4 | — | — | — | 7 | ||
| Adenocarcinoma | D000230 | 3 | 5 | — | — | — | 7 | ||
| Colonic neoplasms | D003110 | C18 | 5 | 3 | — | — | — | 7 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anus neoplasms | D001005 | EFO_0003835 | C21 | 2 | — | — | — | — | 2 |
| Lymphoma | D008223 | C85.9 | 2 | — | — | — | — | 2 | |
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 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 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ERLOTINIB |
| INN | erlotinib |
| Description | Erlotinib is a quinazoline compound having a (3-ethynylphenyl)amino group at the 4-position and two 2-methoxyethoxy groups at the 6- and 7-positions. It has a role as an antineoplastic agent, a protein kinase inhibitor and an epidermal growth factor receptor antagonist. It is a member of quinazolines, a terminal acetylenic compound, an aromatic ether and a secondary amino compound. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1 |
Target
Agency Approved
EGFR
EGFR
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
SLCO2B1
SLCO2B1
Organism
Homo sapiens
Gene name
SLCO2B1
Gene synonyms
KIAA0880, OATP2B1, OATPB, SLC21A9
NCBI Gene ID
Protein name
solute carrier organic anion transporter family member 2B1
Protein synonyms
OATP-B, OATP-RP2, OATP2B1, OATPRP2, Organic anion transporter B, Organic anion transporter polypeptide-related protein 2, Organic anion transporting polypeptide 2B1, solute carrier family 21 (organic anion transporter), member 9, Solute carrier family 21 member 9
Uniprot ID
Mouse ortholog
Slco2b1 (101488)
solute carrier organic anion transporter family member 2B1 (Q8BXB6)
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000016609 | EGFR, 2573T>G, Leu858Arg | drug response | 2021-03-24 | 1A |
| VCV000016613 | EGFR, 2369C>T, Thr790Met | drug response | 2021-03-24 | 2B |
Financial
Tarceva - Roche
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Trends
PubMed Central
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Additional graphs summarizing 38,099 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29 adverse events reported
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