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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 treatment

Place in treatment, anticipated use, and care setting

1 evidence topic · 4 sources

Summary

The proposed post-platinum use includes participants previously treated with or without amivantamab. REZILIENT1 evaluates oral monotherapy, whereas REZILIENT3 evaluates first-line Zipalertinib with platinum-pemetrexed chemotherapy. These regimens and populations should be considered separately. Pre-approval access requests must come from physicians and do not guarantee access.