Dizal Pharmaceutical secured accelerated FDA approval four days ahead of schedule for sunvozertinib (Zegfrovy), targeting non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations after platinum-based chemotherapy. The drug, the only approved oral targeted therapy for this mutation, offers an alternative to Johnson & Johnson’s Rybrevant. Approval was based on response rates from clinical trials, with continued approval pending confirmatory data. Thermo Fisher’s Oncomine Dx Express assay also received FDA clearance as a companion diagnostic for Zegfrovy, enabling more precise patient identification.