On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sunvozertinib for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring 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.
Sunvozertinib is an oral EGFR tyrosine kinase inhibitor. The approval was based on the phase WU-KONG6 multicenter study evaluating sunvozertinib monotherapy in patients with previously treated EGFR exon 20 insertion–positive NSCLC. The objective response rate was 46% with a median duration of response of 11.1 months.
US Food and Drug website. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20. Accessed July 9, 2025.