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| Trade names | 舒沃哲, Zegfrovy |
| AHFS/Drugs.com | Zegfrovy |
| Routes of administration | By mouth |
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| Chemical and physical data | |
| Formula | C29H35ClFN7O3 |
| Molar mass | 584.09 g·mol−1 |
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Sunvozertinib is ananti-cancer medication used for the treatment ofnon-small-cell lung cancer.[2][3] It is anepidermal growth factor receptor (EGFR)tyrosine kinase inhibitor.[2][4]
Sunvozertinib was approved for medical use in the United States in July 2025.[1]
In the US, sunvozertinib isindicated for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.[1]
The US FDA prescribing information for sunvozertinib includes warnings and precautions for interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.[1]
Sunvozertinib is beingdeveloped by Dizal Pharmaceutical.[5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results ofphase 3 clinical trials.[6] In the United States, it has been designated by the Food and Drug Administration as abreakthrough therapy for patients with locally advanced or metastatic NSCLCs with an EGFR exon 20 insertion mutation.[7]
Efficacy was evaluated in WU-KONG1B (NCT03974022), a multinational, open-label, dose randomization trial.[1] Eligible participants had locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations with disease progression on or after platinum-based chemotherapy.[1] The primary efficacy population was in 85 participants who received sunvozertinib 200 mg orally once daily with food until disease progression or intolerable toxicity.[1]
The USFood and Drug Administration granted the application for sunvozertinibpriority review andbreakthrough therapy designations.[1]
This article incorporates text from this source, which is in thepublic domain.