Dizal's ZEGFROVY Receives Priority Review for Lung Cancer Treatment in China
Dizal, a biopharmaceutical company, announced that its New Drug Application (NDA) for ZEGFROVY (sunvozertinib) has been accepted and granted priority review by China's National Medical Products Administration (NMPA). The drug is intended for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This follows previous accelerated approvals by both China's CDE and the U.S. FDA. The NDA is supported by the WU-KONG28 study, which showed significant improvement in progression-free survival compared to chemotherapy. ZEGFROVY has also received Breakthrough Therapy Designations from both the U.S. FDA and China's CDE.