Evicenter
P&T meetings

Zipalertinib

EGFR exon 20 insertion-mutated non-small-cell lung cancer

Also known as CLN-081, TAS6417
Manufacturer
Taiho Oncology
Regulatory submission
NDA submitted February 2026
Launch
Not announced
75 sources

Section 1 of 6

Terms and abbreviations

1 evidence topic · 0 sources

AbbreviationTerm
1LFirst line
AEAdverse event
AHFSAmerican Hospital Formulary Service
ASCOAmerican Society of Clinical Oncology
BIDTwice daily
CASChemical Abstracts Service
cEGFRCommon EGFR mutations
CGPComprehensive genomic profiling
ChTChemotherapy
CIConfidence interval
CLN-081Development code for Zipalertinib
CNSCentral nervous system
CRComplete response
CYPCytochrome P450
DCRDisease control rate
DDIDrug-drug interaction
DFSDisease-free survival
DORDuration of response
ECOG PSEastern Cooperative Oncology Group performance status
EGFREpidermal growth factor receptor
EGFRex20insEGFR exon 20 insertions
ESMOEuropean Society for Medical Oncology
FDAU.S. Food and Drug Administration
HRHazard ratio
IASLCInternational Association for the Study of Lung Cancer
ICERIncremental cost-effectiveness ratio
ICRIndependent central review
LMDLeptomeningeal disease
mDORMedian duration of response
METMesenchymal-epithelial transition factor receptor
mPFSMedian progression-free survival
NDANew Drug Application
NGSNext-generation sequencing
NSCLCNon-small-cell lung cancer
ORRObjective response rate
OSOverall survival
PCRPolymerase chain reaction
PDUFAPrescription Drug User Fee Act
PFSProgression-free survival
PPPMPer patient per month
QALYQuality-adjusted life-year
RANO-BMResponse Assessment in Neuro-Oncology Brain Metastases
RECISTResponse Evaluation Criteria in Solid Tumors
RTRadiotherapy
rwOSReal-world overall survival
SDSSafety data sheet
TAS6417Development code for Zipalertinib
TKITyrosine kinase inhibitor
TmaxTime to maximum plasma concentration
TRAETreatment-related adverse event
WCLCWorld Conference on Lung Cancer
WTWild type
≥2LSecond or later line