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# Dizal NDA for Lung Cancer Drug
- URL: https://www.fdaweb.com/dizal-nda-for-lung-cancer-drug/
- Published: 2024-11-08T12:00:00.000Z
- Updated: 2026-09-14T14:46:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158152

Dizal Pharmaceutical has submitted an NDA for sunvozertinib for treating locally advanced or metastatic non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). The submission is based on data from the WU-KONG1 Part B study that demonstrated sunvozertinib had a statistically significant and clinically meaningful objective response rate, which was the primary endpoint, while maintaining a manageable safety profile, according to the company.

Sunvozertinib is described as an irreversible EGFR inhibitor discovered by Dizal scientists. During clinical trials, most common drug-related adverse events were Grade 1-2 in nature and clinically manageable, the company says.