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Bezuclastinib

Nonadvanced systemic mastocytosis

Manufacturer
Cogent Biosciences
Regulatory submission
NDA submitted December 2025
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Section 1 of 6

Terms and abbreviations

1 evidence topic · 0 sources

AbbreviationTerm
AEAdverse event
AHFSAmerican Hospital Formulary Service
ALTAlanine aminotransferase
ANCOVAAnalysis of covariance
ASTAspartate aminotransferase
BMDBone mineral density
BSCBest supportive care
C7D1Cycle 7, day 1
CIConfidence interval
CNSCentral nervous system
CYP3A4Cytochrome P450 3A4
EAPExpanded access protocol
FDAU.S. Food and Drug Administration
GISTGastrointestinal stromal tumor
GrGrade
H1Histamine H1 receptor
H2Histamine H2 receptor
ICCIntraclass correlation coefficient
ICERIncremental cost-effectiveness ratio
IgEImmunoglobulin E
IQWiGInstitute for Quality and Efficiency in Health Care
ISMIndolent systemic mastocytosis
ISM-SAFIndolent Systemic Mastocytosis Symptom Assessment Form
ITTIntention to treat
KITKIT receptor tyrosine kinase
MCMast cell
MC-QoLMastocytosis Quality of Life Questionnaire
MS2D2Mastocytosis Symptom Severity Daily Diary
NCCNNational Comprehensive Cancer Network
NDANew Drug Application
NonAdvSMNonadvanced systemic mastocytosis
PBOPlacebo
PDUFAPrescription Drug User Fee Act
PGISPatient Global Impression of Severity
PtsPatients
QALYQuality-adjusted life-year
QDOnce daily
SDStandard deviation
SMSystemic mastocytosis
SSMSmoldering systemic mastocytosis
TKITyrosine kinase inhibitor
TRAETreatment-related adverse event
TSSTotal symptom score