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Bezuclastinib

Gastrointestinal stromal tumor

Manufacturer
Cogent Biosciences
Regulatory submission
NDA submitted April 2026
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Section 1 of 6

Terms and abbreviations

1 evidence topic · 0 sources

AbbreviationTerm
AEAdverse event
ALActivation loop
ALTAlanine aminotransferase
APATP-binding pocket
ASCOAmerican Society of Clinical Oncology
ASTAspartate aminotransferase
ATPAdenosine triphosphate
AUCArea under the concentration-time curve
AUCssArea under the concentration-time curve at steady state
BICRBlinded independent central review
BTDBreakthrough Therapy Designation
CASChemical Abstracts Service
CBRClinical benefit rate
CIConfidence interval
CRComplete response
ctDNACirculating tumor DNA
CTOSConnective Tissue Oncology Society
CYP3A4Cytochrome P450 3A4
DLTDose-limiting toxicity
ECOGEastern Cooperative Oncology Group
FDAU.S. Food and Drug Administration
GEISSpanish Group for Research on Sarcomas
GIGastrointestinal
GISTGastrointestinal stromal tumor
HRHazard ratio
HRQoLHealth-related quality of life
KITKIT receptor tyrosine kinase
mPFSMedian progression-free survival
mRECISTModified Response Evaluation Criteria in Solid Tumors
MTDMaximum tolerated dose
mTORMechanistic target of rapamycin
NCCNNational Comprehensive Cancer Network
NDANew drug application
NTRKNeurotrophic receptor tyrosine kinase
ORRObjective response rate
OSOverall survival
PDProgressive disease
PDGFRPlatelet-derived growth factor receptor
PDGFRAPlatelet-derived growth factor receptor alpha
PDUFAPrescription Drug User Fee Act
PFSProgression-free survival
PKPharmacokinetics
PRPartial response
QALYQuality-adjusted life-year
QDOnce daily
RECISTResponse Evaluation Criteria in Solid Tumors
RP2DRecommended phase 2 dose
RTORReal-Time Oncology Review
SCFStem cell factor
SCFRStem cell factor receptor
SDStable disease or standard deviation, according to context
TKITyrosine kinase inhibitor
TRAETreatment-related adverse event
TRKTropomyosin receptor kinase