Sunvozertinib

Sunvozertinib is an anti-cancer medication used for the treatment of non-small-cell lung cancer. It is an epidermal growth factor receptor tyrosine kinase inhibitor.
Sunvozertinib was approved for medical use in the United States in July 2025.

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.

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.

History

Sunvozertinib is being developed by Dizal Pharmaceutical. 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. 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.
Efficacy was evaluated in WU-KONG1B, a multinational, open-label, dose randomization trial. 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. The primary efficacy population was in 85 participants who received sunvozertinib 200 mg orally once daily with food until disease progression or intolerable toxicity.
The US Food and Drug Administration granted the application for sunvozertinib priority review and breakthrough therapy designations.