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Zipalertinib (CLN-081)

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

Also known as TAS6417
Manufacturer
Taiho Oncology
Regulatory submission
NDA submitted February 2026
Launch
Not announced
Last updated
75 sources

Executive summary

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

1 evidence topic · 3 sources

Summary

In a genomic-profiling series of 14,483 NSCLC cases, 263 (1.8%) had EGFR exon 20 insertions, representing 12% of EGFR-mutated cases. These are case-series frequencies, not population incidence rates. A retrospective comparison reported median real-world overall survival of 16.2 months with exon 20 insertions versus 25.5 months with common EGFR mutations. A separate analysis projected that PCR-based assays would miss approximately 50% of variants identified by NGS.