The U.S. Food and Drug Administration granted accelerated approval to Dizal Pharmaceutical's sunvozertinib (Zegfrovy) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations after platinum-based chemotherapy. This approval designates sunvozertinib as the only targeted oral treatment for this rare NSCLC subtype and follows priority review and breakthrough therapy designations. The decision is based on overall response rates and duration of response, with continued approval contingent on confirmatory trials. Thermo Fisher’s Oncomine Dx Express Test received FDA clearance as a companion diagnostic for this therapy, promoting precise patient identification in decentralized clinical settings.