The U.S. FDA has approved China-based Dizal Pharmaceutical’s oral EGFR inhibitor, Zegfrovy, for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20ins.
The indication is approved under accelerated approval based on overall response rate and duration of response, with continued approval contingent on verification in a confirmatory trial.
Zegfrovy is the only approved targeted oral treatment for NSCLC with EGFR exon20ins—the third most common type of EGFR mutation in NSCLC. The once-daily tablets were granted accelerated approval in China in August 2023.
The drug is an irreversible EGFR inhibitor with uniquely designed molecular structure targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity.
The FDA simultaneously approved Thermo Fisher Scientific's Oncomine Dx Express Test as a next-generation sequencing companion diagnostic for Zegfrovy to identify NSCLC patients with EGFR Exon20 insertions.