Zipalertinib (CLN-081)

Name: Zipalertinib (CLN-081) in EGFR exon 20 insertion-mutated non-small-cell lung cancer: Diagnosis
Published: 2026-09-14T15:39:06-04:00

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: September 19, 2026

Section

Product information and disease description Place of product in therapy Disease description

Diagnosis

2 evidence topics · 6 sources

Diagnostic testing and underdiagnosis

“An analysis of variants projected that ~ 50% of EGFR ex20ins identified by NGS would have been missed by PCR-based assays.” (opens the source at this quote in a new tab)

Guideline preference for multiplex molecular testing

“If available, multiplex platforms (NGS) for molecular testing are preferable” (opens the source at this quote in a new tab)