Lorbrena, Lorviqua(lorlatinib)
Lorbrena, Lorviqua (lorlatinib) is a small molecule pharmaceutical. Lorlatinib was first approved as Lorbrena on 2018-11-02. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against proto-oncogene tyrosine-protein kinase ROS and ALK tyrosine kinase receptor. In addition, it is known to target tyrosine-protein kinase Fes/Fps.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Lorbrena
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lorbrena | New Drug Application | 2025-05-01 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LORLATINIB, LORBRENA, PFIZER | |||
| 2028-03-03 | ODE-349 | ||
| 2025-11-02 | ODE-217, ODE-218, ODE-219 | ||
| 2024-03-03 | I-847 | ||
HCPCS
No data
Clinical
Clinical Trials
71 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 | — | — | 7 | 21 | 1 | 5 | 20 | 50 |
| Lung neoplasms | D008175 | — | C34.90 | 4 | 14 | — | 2 | 6 | 23 |
| Neoplasms | D009369 | — | C80 | 4 | 4 | — | 1 | — | 7 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 3 | — | 1 | 1 | 6 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 2 | — | 1 | 1 | 4 |
| Second primary neoplasms | D016609 | — | — | — | — | — | 1 | 1 | 2 |
| Meningeal carcinomatosis | D055756 | EFO_1001012 | — | — | — | — | 1 | 1 | 2 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | 1 | — | 1 |
| Disease resistance | D060467 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | 1 | — | 1 | 3 |
| Ganglioneuroblastoma | D018305 | — | — | — | — | 1 | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | — | 1 | — | — | 1 |
| Adenocarcinoma of lung | D000077192 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 1 | 2 | — | — | 1 | 3 |
| Disease progression | D018450 | — | — | 1 | 1 | — | — | — | 2 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | — | 1 | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | — | 7 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 2 | — | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Small cell lung carcinoma | D055752 | — | — | — | — | — | — | 1 | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 1 | 1 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | — | — | — | — | 1 | 1 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | — | — | 1 | 1 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | — | — | 1 | 1 |
| Hyperlipoproteinemias | D006951 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lorlatinib |
| INN | lorlatinib |
| Description | Lorlatinib is a cyclic ether that is 16,17-dihydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecin-15(10H)-one substituted by methyl groups at positions 2 and 10R, and by cyano, amino and fluoro groups at positions 3, 7 and 12 respectively. It is a small molecule inhibitor of ALK and ROS1 kinase developed by Pfizer for the treatment of ALK-positive non-small cell lung cancer. It has a role as an antineoplastic agent and an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor. It is a member of pyrazoles, a member of monofluorobenzenes, an aromatic ether, a nitrile, a member of benzamides, an azamacrocycle, an aminopyridine, a cyclic ether and an organic heterotetracyclic compound. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H]1Oc2cc(cnc2N)-c2c(nn(C)c2C#N)CN(C)C(=O)c2ccc(F)cc21 |
Identifiers
| PDB | — |
| CAS-ID | 1454846-35-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3286830 |
| ChEBI ID | — |
| PubChem CID | 71731823 |
| DrugBank | DB12130 |
| UNII ID | OSP71S83EU (ChemIDplus, GSRS) |
Target
Agency Approved
ROS1
ROS1
ALK
ALK
Organism
Homo sapiens
Gene name
ROS1
Gene synonyms
MCF3, ROS
NCBI Gene ID
Protein name
proto-oncogene tyrosine-protein kinase ROS
Protein synonyms
c-ros oncogene 1 , receptor tyrosine kinase, c-Ros receptor tyrosine kinase, Proto-oncogene c-Ros, Proto-oncogene c-Ros-1, Receptor tyrosine kinase c-ros oncogene 1, ROS proto-oncogene 1 , receptor tyrosine kinase, transmembrane tyrosine-specific protein kinase, v-ros avian UR2 sarcoma virus oncogene homolog 1
Uniprot ID
Mouse ortholog
Ros1 (19886)
proto-oncogene tyrosine-protein kinase ROS (Q78DX7)
Alternate
FES
FES
Organism
Homo sapiens
Gene name
FES
Gene synonyms
FPS
NCBI Gene ID
Protein name
tyrosine-protein kinase Fes/Fps
Protein synonyms
feline sarcoma (Snyder-Theilen) viral (v-fes)/Fujinami avian sarcoma (PRCII) viral (v-fps) oncogene homolog, feline sarcoma oncogene, Feline sarcoma/Fujinami avian sarcoma oncogene homolog, Oncogene FES, feline sarcoma virus, p93c-fes, Proto-oncogene c-Fes, Proto-oncogene c-Fps, proto-oncogene tyrosine-protein kinase Fes/Fps
Uniprot ID
Mouse ortholog
Fes (14159)
tyrosine-protein kinase Fes/Fps (Q8CG02)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Lorbrena – Pfizer
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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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5,557 adverse events reported
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