Dizal Pharmaceutical obtained accelerated FDA approval for sunvozertinib (Zegfrovy) to treat adults with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations after platinum-based chemotherapy. The therapy, the first targeted oral treatment approved for this specific rare genetic subset, received priority review and breakthrough therapy designations. Approval was based on overall response rates, with continued authorization contingent on confirmatory data. The companion diagnostic for mutation detection also gained FDA clearance, enhancing precision oncology options for patients with these difficult-to-treat tumors.