Treats locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal…. NDA 219839, held by Dizal. Sunvozertinib.
As of Nov 14, 2026, NDA 219839 (Zegfrovy), held by Dizal, was first approved by FDA on Jul 2, 2025, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE ZEGFROVY is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ZEGFROVY is a kinase inhibitor
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 2, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Zegfrovy150MG · tablet;oral | Sunvozertinib | RxReference drug |
| Zegfrovy200MG · tablet;oral | Sunvozertinib | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
