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Tovorafenib

RAF-altered pediatric low-grade glioma requiring first-line systemic therapy

Also known as DAY101, TAK-580
Regulatory submission
Not announced
Launch
Not announced
155 sources

Section 1 of 6

Terms and abbreviations

1 evidence topic · 0 sources

AbbreviationTerm
ACTHAdrenocorticotropic hormone
ADLTAdvanced diagnostic laboratory test
ADRAdverse drug reaction
AEAdverse event
AESIAdverse event of special interest
AGVAnnualized growth velocity
AHFSAmerican Hospital Formulary Service
ALKAnaplastic lymphoma kinase
ALTAlanine aminotransferase
ANOVAAnalysis of variance
APCAnnual percent change
ARAFA-Raf proto-oncogene, serine/threonine kinase
ASHPAmerican Society of Health-System Pharmacists
ASTAspartate aminotransferase
ATCAnatomical Therapeutic Chemical classification
AUCArea under the concentration-time curve
BCRPBreast cancer resistance protein
BCVABest-corrected visual acuity
BFSBlindness-free survival
BLBaseline
BORBest overall response
BRAFB-Raf proto-oncogene, serine/threonine kinase
BRAFiBRAF inhibitor
BSABody surface area
BTGBrain Tumour Group
CADCanadian dollars
CAPCollege of American Pathologists
CBRClinical benefit rate
CBTRUSCentral Brain Tumor Registry of the United States
CCLGChildren's Cancer and Leukaemia Group
CDA-AMCCanada's Drug Agency (formerly CADTH)
CDKN2ACyclin-dependent kinase inhibitor 2A
CFRCode of Federal Regulations
CHGChiasmatic-hypothalamic glioma
CHMPCommittee for Medicinal Products for Human Use
CIConfidence interval
CL/FApparent oral clearance
CLIAClinical Laboratory Improvement Amendments
CMAConditional marketing authorisation
CmaxMaximum plasma concentration
CminMinimum plasma concentration
CMSCenters for Medicare and Medicaid Services
CNSCentral nervous system
CNS5Fifth edition of the WHO Classification of Tumors of the Central Nervous System
COGChildren's Oncology Group
CPKCreatine phosphokinase
CRComplete response
CRAFC-Raf proto-oncogene, serine/threonine kinase (RAF1)
CTCAECommon Terminology Criteria for Adverse Events
CVCarboplatin and vincristine
CVFQChildren's Visual Function Questionnaire
CYPCytochrome P450
D+TDabrafenib plus trametinib
Dab-TramDabrafenib plus trametinib
DDIDrug-drug interaction
DLTDose-limiting toxicity
DMCData monitoring committee
DNADeoxyribonucleic acid
DORDuration of response
DOTDuration of treatment
DSDiencephalic syndrome
DTDistress Thermometer
ECEuropean Commission
ECHOEchocardiogram
EFEjection fraction
EFSEvent-free survival
eGFREstimated glomerular filtration rate
EHRElectronic health record
EMAEuropean Medicines Agency
EORTCEuropean Organisation for Research and Treatment of Cancer
EREmergency room
ERKExtracellular signal-regulated kinase
ESSEffective sample size
EUEuropean Union
FDAUS Food and Drug Administration
FDCAFederal Food, Drug, and Cosmetic Act
FEPFederal Employee Program
FFPEFormalin-fixed, paraffin-embedded
FGFRFibroblast growth factor receptor
FISHFluorescence in situ hybridization
FLAIRFluid-attenuated inversion recovery
FTFinancial toxicity
G-BAGemeinsamer Bundesausschuss (Federal Joint Committee, Germany)
GBGGliome de bas grade (low-grade glioma)
GGGanglioglioma
GHGrowth hormone
GIGastrointestinal
GKVGesetzliche Krankenversicherung (statutory health insurance, Germany)
GnRHGonadotropin-releasing hormone
GTRGross total resection
GVGrowth velocity
HASHaute Autorité de santé (French National Authority for Health)
HGGHigh-grade glioma
HIHepatic impairment
HRHazard ratio
HRQoLHealth-related quality of life
HRUHealthcare resource utilization
HSRHypersensitivity reaction
HTAHealth technology assessment
HTACGMember State Coordination Group on Health Technology Assessment
HTDHealth technology developer
IC50Half-maximal inhibitory concentration
ICD-10International Classification of Diseases, Tenth Revision
ICD-O-3International Classification of Diseases for Oncology, Third Edition
ICERIncremental cost-effectiveness ratio; Institute for Clinical and Economic Review
ICHIntracranial hemorrhage
IDHIsocitrate dehydrogenase
IHCImmunohistochemistry
INDInvestigational new drug application
INVInvestigator
IQIntelligence quotient
IQRInterquartile range
IQWiGInstitut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care, Germany)
IRCIndependent review committee
ITDsInternal tandem duplications
ITHIntratumoral hemorrhage
ITTIntention to treat
IVIntravenous
JCAJoint Clinical Assessment
LDHLactate dehydrogenase
LGGLow-grade glioma
LOGGICLow-Grade Glioma in Children consortium (SIOPe Brain Tumour Group)
logMARLogarithm of the minimum angle of resolution
LTFULong-term follow-up
MAHMarketing authorisation holder
MAICMatching-adjusted indirect comparison
MAPKMitogen-activated protein kinase
MAPKiMAPK pathway inhibitor
MATEMultidrug and toxin extrusion protein
MDRDModification of Diet in Renal Disease
MEKMitogen-activated protein kinase kinase
MEKiMEK inhibitor
MHLWMinistry of Health, Labour and Welfare (Japan)
MRMinor response
MRIMagnetic resonance imaging
MTDMaximum tolerated dose
MYBLMYB proto-oncogene like
NANot applicable
NCCNNational Comprehensive Cancer Network
NDANew drug application
NDCNational Drug Code
NENot evaluable
NF-1Neurofibromatosis type 1
NF-2Neurofibromatosis type 2
NF1Neurofibromatosis type 1 (gene: neurofibromin 1)
NF1-LOFNeurofibromatosis type 1 loss of function
NGSNext-generation sequencing
NICENational Institute for Health and Care Excellence
NOPHONordic Society of Paediatric Haematology and Oncology
NRNot reached
NTRKNeurotrophic tyrosine receptor kinase
OATOrganic anion transporter
OATPOrganic anion-transporting polypeptide
OCTOrganic cation transporter
OISOncogene-induced senescence
OPGOptic pathway glioma
OROdds ratio
ORROverall (objective) response rate
OSOverall survival
P-gpP-glycoprotein
PAPilocytic astrocytoma
PBPKPhysiologically based pharmacokinetic
PBTCPediatric Brain Tumor Consortium
PBTSPediatric brain tumor survivors
PDProgressive disease; pharmacodynamics (in PK/PD)
PedsQLPediatric Quality of Life Inventory
pERKPhosphorylated extracellular signal-regulated kinase
PFSProgression-free survival
PICOPopulation, intervention, comparator, outcome
PKPharmacokinetics
PLGAPediatric low-grade astrocytoma
PLGGPediatric low-grade glioma
pLGGPediatric low-grade glioma
PMRPostmarketing requirement
PNPlexiform neurofibroma
popPKPopulation pharmacokinetics
PPKPopulation pharmacokinetics
PRPartial response
PROPatient-reported outcome
PROMISPatient-Reported Outcomes Measurement Information System
PSURPeriodic safety update report
pUPharmazeutischer Unternehmer (pharmaceutical company)
PXAPleomorphic xanthoastrocytoma
Q2DOnce every other day
QALYQuality-adjusted life-year
QOLQuality of life
QoLQuality of life
QTQT interval (electrocardiogram)
QWOnce weekly
RAFRapidly accelerated fibrosarcoma kinase
RANOResponse Assessment in Neuro-Oncology
RANO-HGGResponse Assessment in Neuro-Oncology criteria for high-grade glioma
RANO-LGGResponse Assessment in Neuro-Oncology criteria for low-grade glioma
RAPNOResponse Assessment in Pediatric Neuro-Oncology
RAPNO-LGGResponse Assessment in Pediatric Neuro-Oncology criteria for low-grade glioma
RASRat sarcoma virus GTPase
RCTRandomized controlled trial
RECISTResponse Evaluation Criteria in Solid Tumors
REMSRisk Evaluation and Mitigation Strategy
RIRenal impairment
RNARibonucleic acid
RP2DRecommended phase 2 dose
RRRelative risk; rebound regrowth
RSRetrospective study
RTRadiotherapy
SAESerious adverse event
SASPSenescence-associated secretory phenotype
SDStable disease; standard deviation
SEERSurveillance, Epidemiology, and End Results
SESSocioeconomic status
SIOPInternational Society of Paediatric Oncology
SIOP-LGGInternational Society of Paediatric Oncology Low Grade Glioma study
SIOPESIOP Europe (European Society for Paediatric Oncology)
SIOPeSIOP Europe (European Society for Paediatric Oncology)
SmPCSummary of product characteristics
sNDASupplemental new drug application
SNVSingle nucleotide variant
SOBSpecific obligation
SOCStandard of care
SoCStandard of care
SPFSun protection factor
Sub-TITESubgroup-specific time-to-event continual reassessment design
TATTurnaround time
TEAETreatment-emergent adverse event
TFITreatment-free interval
TmaxTime to maximum plasma concentration
TPCVThioguanine, procarbazine, lomustine, and vincristine
TRAETreatment-related adverse event
TTNTTime to next treatment
TTOTime to onset
TTRTime to response
UKUnited Kingdom
ULNUpper limit of normal
USUnited States
USDUnited States dollars
USPIUS Prescribing Information
V/CVincristine and carboplatin
VAVisual acuity
VABSVineland Adaptive Behavior Scales
VBLVinblastine
VCVincristine and carboplatin
VCEVincristine, carboplatin, and etoposide
VFVisual field
VIVisual impairment
VPVisual pathway
WACWholesale acquisition cost
WGWorking group
WHOWorld Health Organization
WTWild-type