Dizal Pharmaceutical Co., Ltd.

Dizal Submits NDA to FDA for Sunvozertinib in EGFR Exon20ins NSCLC

- Dizal has submitted an NDA to the FDA for sunvozertinib to treat NSCLC patients with EGFR exon 20 insertion mutations after platinum-based chemotherapy. - The application is supported by the WU-KONG1 Part B study, which showed statistically significant and clinically meaningful objective response rate (ORR). - Sunvozertinib is an irreversible EGFR inhibitor and has already received accelerated approval in China for the same indication. - Ongoing global pivotal studies are evaluating sunvozertinib in both 1st and 2nd line settings for NSCLC patients with EGFR exon20ins.