Perjeta
E46091
Perjeta is a monoclonal antibody drug used in combination therapies to treat HER2-positive breast cancer.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
HER2-targeted therapy
→
antineoplastic agent → monoclonal antibody drug → |
| approvedBy |
European Medicines Agency
→
U.S. Food and Drug Administration → |
| belongsToRegimen |
CLEOPATRA regimen
→
|
| bindsTo |
HER2 dimerization domain
→
|
| blackBoxWarning |
embryo-fetal toxicity
→
|
| clinicalTrial |
APHINITY trial
→
CLEOPATRA trial → |
| commonAdverseEffect |
alopecia
→
diarrhea → fatigue → nausea → neutropenia → rash → |
| contraindication |
pregnancy
→
|
| EMAPositiveOpinionYear |
2013
→
|
| FDAApprovalYear |
2012
→
|
| hasAntibodyType |
IgG1
→
|
| hasATCCode |
L01FD02
→
|
| hasDosageForm |
concentrate for solution for infusion
→
|
| hasDrugClass |
humanized monoclonal antibody
→
|
| hasGenericName |
pertuzumab
→
|
| hasManufacturer |
Genentech
→
|
| hasMolecularType |
recombinant humanized monoclonal antibody
→
|
| hasParentCompany |
Roche
→
|
| hasTarget |
ERBB2
→
HER2 receptor → |
| improvesOutcome |
overall survival in HER2-positive metastatic breast cancer
→
progression-free survival in HER2-positive metastatic breast cancer → |
| indication |
HER2-positive early breast cancer
→
HER2-positive locally advanced breast cancer → HER2-positive metastatic breast cancer → |
| inhibits |
HER2 dimerization
→
|
| isPatentProtected |
true
→
|
| mechanismOfAction |
induces antibody-dependent cell-mediated cytotoxicity
→
inhibits HER2 signaling pathways → prevents ligand-dependent HER2 heterodimerization → |
| regulatoryStatus |
prescription-only medicine
→
|
| requiresMonitoring |
left ventricular ejection fraction
→
|
| routeOfAdministration |
intravenous infusion
→
|
| seriousAdverseEffect |
congestive heart failure
→
left ventricular dysfunction → |
| usedInCombinationWith |
chemotherapy
→
docetaxel → trastuzumab → |