Zegfrovy (Sunvozertinib) from Dizal: US FDA OKs First-of-Its-Kind Lung Cancer Pill (July 2025)
Eight years after it was established partly by AstraZeneca, Dizal Pharmaceuticals has gained its first FDA approval , winning an accelerated nod for Zegfrovy (sunvozertinib) to become the only U.S.-endorsed oral treatment for those with a rare type of non-small cell lung cancer (NSCLC). Patients in the U.S. with EGFR exon 20 insertion mutations whose cancer has progressed after platinum-based chemotherapy are now eligible for Zegfrovy. The blessing comes 16 months after the FDA signed off on Johnson & Johnson’s infused Rybrevant in combination with chemotherapy as a first-line treatment in the indication. While Rybrevant is an EGFR-MET bispecific antibody, Zegfrovy is a first-in-class selective EGFR tyrosine kinase inhibitor (TKI). “(Zegfrovy) offers a more effective treatment option with enhanced safety and ease of administration for NSCLC patients with EGFR exon 20 insertions,” Dizal CEO Xiaolin Zhang, Ph.D., said in a release. While Zhang's comment suggests Zegfrovy's ...