Dizal, a biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to ZEGFROVY (sunvozertinib) for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. The approval applies to patients whose disease has progressed after platinum-based chemotherapy. ZEGFROVY is the only FDA-approved targeted oral therapy for this NSCLC subtype and received Priority Review and Breakthrough Therapy Designation. Dizal is a biopharmaceutical company focused on developing novel therapies for cancer and immunological diseases. “We are proud to have developed ZEGFROVY, a first-in-class oral therapy that offers a more effective treatment option with enhanced safety and ease of administration,” said Dr. Xiaolin Zhang, CEO of Dizal.
The FDA’s decision is based on findings from the multinational WU-KONG1B study, which showed ZEGFROVY's consistent efficacy across patient groups. “Its convenient once-daily oral dosing substantially improves administration convenience and patient adherence,” said Dr. Pasi A. Jänne of Harvard Medical School. The Oncomine Dx Express Test by Thermo Fisher Scientific was also approved as a companion diagnostic to identify eligible patients. ZEGFROVY demonstrated a manageable safety profile and promising activity across additional EGFR mutations and HER2 exon20ins.
