Dizal Pharmaceutical received accelerated FDA approval for sunvozertinib (Zegfrovy), its targeted oral therapy for non-small cell lung cancer with EGFR exon 20 insertion mutations in patients previously treated with platinum chemotherapy. As the only approved targeted oral option for this mutation, sunvozertinib has priority review and breakthrough designations. Dizal positions the drug as potentially safer and more effective than Johnson & Johnson’s Rybrevant, creating heightened competition in this niche lung cancer segment. Companion diagnostics using Thermo Fisher’s Oncomine Dx Express Test were also approved to identify eligible patients for treatment.