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FEB 27 2027
UPCOMING · 151 DAYS TO PDUFA

Cullinan Therapeutics — zipalertinib $CGEM

for EGFR exon 20 insertion-positive non-small cell lung cancer

NDA · Standard Review

Accepted APR 28 2026.

About

Lung cancer starts when genetic damage to airway cells — often from cigarette smoke or harmful chemicals — lets those cells multiply out of control and form a tumor that can spread throughout the lungs and eventually to other parts of the body. Zipalertinib is an oral medicine that blocks a specific mutated version of the EGFR protein, called an exon 20 insertion, which drives some lung tumors to grow. Because that mutation is what keeps these cancer cells dividing, shutting it down may help slow or stop the disease.

Pivotal trial

REZILIENT4 Phase 3 active not recruiting NCT07128199

The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).

Source: ClinicalTrials.gov

Also in development