Sunvozertinib (Zegfrovy) has been greenlit by the FDA for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.1
Officials with the FDA also approved the Oncomine Dx Express Test as a companion diagnostic device to aid in detecting EGFR exon 20 insertion mutations in patients with NSCLC who may be eligible for treatment with sunvozertinib.
The approval was based on efficacy data from WU-KONG1B (NCT03974022), a multinational, open-label, dose-randomization trial. Eligible patients had locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations with disease progression on or after platinum-based chemotherapy. The primary efficacy population was 85 patients who received sunvozertinib 200 mg orally once daily with food until disease progression or intolerable toxicity.
The major efficacy outcome measure was a confirmed overall response rate, according to RECIST v1.1 as evaluated by a blinded independent review committee (BIRC). An additional efficacy outcome measure was duration of response by BIRC. The overall response rate was 46% (95% CI, 35-37), and duration of response was 11.1 months (95% CI, 8.2-not evaluable).
The sunvozertinib prescribing information includes warnings and precautions for interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.
The recommended sunvozertinib dose is 200 mg orally once daily with food until disease progression or unacceptable toxicity.
Reference
- US Food and Drug Administration. FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. July 2, 2025. Accessed August 14, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20