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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

Product information and disease descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care

Limitations of current therapies

1 evidence topic · 6 sources

Summary

Amivantamab with platinum-based chemotherapy is recommended for first-line treatment, and sunvozertinib has accelerated approval after platinum-based chemotherapy. Activity in one line of treatment does not establish comparative effectiveness in another. WU-KONG28 reported objective responses in 58.9% with sunvozertinib and 31.1% with chemotherapy. The evidence assembled here does not provide a randomized comparison of Zipalertinib against amivantamab-containing therapy or sunvozertinib.