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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
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Lorbrena
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lorlatinib
Tradename
Company
Number
Date
Products
LORBRENAMylanN-210868 RX2018-11-02
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lorbrenaNew Drug Application2023-03-22
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
LORLATINIB, LORBRENA, PFIZER
2028-03-03ODE-349
2025-11-02ODE-217, ODE-218, ODE-219
2024-03-03I-847
2023-11-02NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Lorlatinib, Lorbrena, Pfizer
112995002038-10-04DP
104207492036-07-27DS, DPU-2633, U-3096
110203762036-07-27DP
86801112033-03-05DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01ED: Anaplastic lymphoma kinase (alk) inhibitors
— L01ED05: Lorlatinib
HCPCS
No data
Clinical
Clinical Trials
42 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 carcinomaD00228941113420
NeoplasmsD009369C8033—1—6
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_00006211—1—13
GanglioneuroblastomaD018305——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175C34.9012———2
Large-cell lymphoma anaplasticD017728C84.6—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
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Hematologic neoplasmsD0193371————1
Prostatic neoplasmsD011471C611————1
Castration-resistant prostatic neoplasmsD0641291————1
Breast neoplasmsD001943EFO_0003869C501————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Non-hodgkin lymphomaD008228C85.91————1
Primary myelofibrosisD055728D47.41————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 carcinomaD055752————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLORLATINIB
INNlorlatinib
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 classtyrosine 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-ID1454846-35-5
RxCUI2103164
ChEMBL IDCHEMBL3286830
ChEBI ID—
PubChem CID71731823
DrugBankDB12130
UNII IDOSP71S83EU (ChemIDplus, GSRS)
Target
Agency Approved
ROS1
ROS1
ALK
ALK
Organism
Homo sapiens
Gene name
ROS1
Gene synonyms
MCF3, ROS
NCBI Gene ID
6098
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
Q5TDB5
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
2242
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
P07332
Mouse ortholog
Fes (14159)
tyrosine-protein kinase Fes/Fps (Q8CG02)
Variants
Clinical Variant
No data
Financial
Lorbrena - Pfizer
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,810 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,107 adverse events reported
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