Ahead of its scheduled PDUFA date, the FDA granted accelerated approval to Dizal Pharmaceutical's sunvozertinib (Zegfrovy) for adults with locally advanced or metastatic non-small-cell lung cancer harboring EGFR exon 20 insertion mutations. The indication applies following prior platinum-based chemotherapy. The rapid approval underscores the agency's support for novel targeted therapies addressing unmet needs in lung cancer patients with specific molecular profiles.