Sunvozertinib
Pharmaceutical drug
From Wikipedia, the free encyclopedia
Sunvozertinib is an anti-cancer medication used for the treatment of non-small-cell lung cancer.[2][3] It is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.[2][4]
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| Trade names | 舒沃哲, Zegfrovy |
| AHFS/Drugs.com | Zegfrovy |
| Routes of administration | By mouth |
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| Formula | C29H35ClFN7O3 |
| Molar mass | 584.09 g·mol−1 |
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Sunvozertinib was approved for medical use in the United States in July 2025.[1]
Medical uses
In the US, sunvozertinib is indicated 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]
Side effects
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]
History
Sunvozertinib is being developed by Dizal Pharmaceutical.[5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results of phase 3 clinical trials.[6] In the United States, it has been designated by the Food and Drug Administration as a breakthrough 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 US Food and Drug Administration granted the application for sunvozertinib priority review and breakthrough therapy designations.[1]
