FDA Approves Sunvozertinib for EGFR Exon 20-Mutated Metastatic Non-Small Cell Lung Cancer
On July 2, 2025, the US Food and Drug Administration (FDA) granted accelerated approval to sunvozertinib (Zegfrovy; Dizal Pharmaceutical Co, Ltd) for the treatment of adult 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.
This approval is based on efficacy data from the WU-KONG1B trial, a multinational, open-label, dose-randomization study. In this trial, 85 patients received sunvozertinib 200 mg orally once daily with food until disease progression or intolerable toxicity. The primary efficacy outcome measure was confirmed overall response rate (ORR) according to RECIST v1.1 as evaluated by a blinded independent review committee.
Results from the trial showed an ORR of 46% (95% confidence interval [CI], 35, 57), and the median duration of response (DOR) was 11.1 months (95% CI, 8.2, not evaluable).
The FDA also approved the Oncomine Dx Express Test (Life Technologies Corporation) 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 prescribing information for sunvozertinib includes warnings and precautions for interstitial lung disease (ILD)/pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity. The recommended dose is 200 mg orally once daily with food until disease progression or unacceptable toxicity.
This accelerated approval provides a new treatment option for patients with EGFR exon 20 insertion-mutated NSCLC, a population with limited targeted therapies. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Source:
US Food and Drug Administration. FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. FDA. Published July 2, 2025. Accessed July 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20
