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# Dizal Lung Cancer NDA Accepted for Priority Review
- URL: https://www.fdaweb.com/dizal-lung-cancer-nda-accepted-for-priority-review/
- Published: 2025-01-07T12:00:00.000Z
- Updated: 2026-09-14T14:50:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158444

FDA has accepted for priority review biopharmaceutical firm Dizal’s NDA for sunvozertinib, an oral EGFR inhibitor for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) whose disease has progressed on or after platinum-based chemotherapy. The submission is based on data from the pivotal WU-KONG1 Part B study that showed sunvozertinib had “encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins,” the company says.

Regarding safety, sunvozertinib showed a well-tolerated and manageable safety, Dixal says. The most common drug-related treatment-emergent adverse events were Grade 1-2 in severity and clinically manageable, it adds.