Dizal Pharmaceutical received FDA accelerated approval for sunvozertinib (Zegfrovy), an oral EGFR exon 20 insertion mutation inhibitor for advanced non-small-cell lung cancer post chemotherapy. This marks the only approved targeted oral therapy for this indication, benefiting from priority review and breakthrough therapy designations. The drug sets up direct competition with Johnson & Johnson’s Rybrevant, with Dizal claiming improved safety and efficacy profiles. The approval is contingent on confirmatory trials. Simultaneously, the Oncomine Dx Express test by Thermo Fisher gained FDA clearance as a companion diagnostic for sunvozertinib and for broad solid tumor profiling, facilitating precision medicine approaches.