Tarceva(erlotinib)
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
Therapeutic Areas
Trade Name
FDA
EMA
Erlotinib (discontinued: Erlotinib, Tarceva)
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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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| erlotinib | ANDA | 2024-11-28 |
| erlotinib hydrochloride | ANDA | 2024-06-10 |
| 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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HCPCS
No data
Clinical
Clinical Trials
869 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 | — | — | 100 | 248 | 69 | 12 | 50 | 431 |
| Lung neoplasms | D008175 | — | C34.90 | 73 | 172 | 41 | 8 | 47 | 304 |
| Neoplasms | D009369 | — | C80 | 69 | 41 | 7 | 1 | 11 | 119 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 31 | 53 | 7 | 1 | 3 | 88 |
| Carcinoma | D002277 | — | C80.0 | 15 | 38 | 6 | 1 | 4 | 55 |
| Adenocarcinoma | D000230 | — | — | 11 | 28 | 2 | 3 | 4 | 40 |
| Adenocarcinoma of lung | D000077192 | — | — | 8 | 29 | 2 | 2 | 4 | 39 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 5 | 18 | 6 | 1 | 3 | 32 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 4 | 12 | — | 1 | — | 14 |
| Exanthema | D005076 | — | — | — | 4 | 1 | 1 | 1 | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 13 | 22 | 6 | — | 1 | 37 |
| Squamous cell carcinoma | D002294 | — | — | 15 | 21 | 4 | — | 3 | 36 |
| Head and neck neoplasms | D006258 | — | — | 16 | 16 | 2 | — | 1 | 31 |
| Colorectal neoplasms | D015179 | — | — | 5 | 16 | 3 | — | 1 | 23 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 11 | 15 | 1 | — | — | 23 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 7 | 13 | 1 | — | — | 18 |
| Squamous cell neoplasms | D018307 | — | — | 3 | 11 | 3 | — | 2 | 17 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 4 | 11 | 1 | — | — | 14 |
| Rectal neoplasms | D012004 | — | — | 8 | 6 | 1 | — | — | 12 |
| Esophageal neoplasms | D004938 | — | C15 | 4 | 7 | 1 | — | — | 12 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 11 | 22 | — | — | 2 | 29 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 9 | 18 | — | — | 1 | 26 |
| Glioblastoma | D005909 | EFO_0000515 | — | 9 | 17 | — | — | — | 21 |
| Glioma | D005910 | EFO_0000520 | — | 11 | 9 | — | — | 1 | 18 |
| Gliosarcoma | D018316 | — | — | 6 | 12 | — | — | — | 15 |
| Bronchiolo-alveolar adenocarcinoma | D002282 | — | — | 1 | 12 | — | — | 1 | 14 |
| Central nervous system neoplasms | D016543 | — | — | 4 | 6 | — | — | 1 | 10 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 7 | 4 | — | — | — | 9 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 4 | 5 | — | — | — | 9 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 3 | 5 | — | — | — | 8 |
Show 123 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | 1 | 2 |
| Anus neoplasms | D001005 | EFO_0003835 | C21 | 2 | — | — | — | — | 2 |
| Primitive neuroectodermal tumors | D018242 | — | — | 2 | — | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 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 |
Show 33 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | — | 1 | 1 |
| Second primary neoplasms | D016609 | — | — | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Germ-line mutation | D018095 | — | — | — | — | — | — | 1 | 1 |
| Multiple primary neoplasms | D009378 | — | — | — | — | — | — | 1 | 1 |
| Eye abnormalities | D005124 | — | Q15.9 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | — | — | — | 1 | 1 |
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 |
Identifiers
| PDB | — |
| CAS-ID | 183321-74-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL553 |
| ChEBI ID | 114785 |
| PubChem CID | 176870 |
| DrugBank | DB00530 |
| UNII ID | J4T82NDH7E (ChemIDplus, GSRS) |
Target
Agency Approved
No data
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
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Financial
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Tarceva – Roche
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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49,114 adverse events reported
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