FDA Approves Sunvozertinib in Non–Small Cell Lung Cancer

The FDA granted an accelerated approval for sunvozertinib (Zegfrovy; Dizal) on June 2, 2025, marking the first and only targeted oral treatment for patients with non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.¹ Specifically, this treatment can be used in those whose disease has progressed either during or after platinum-based chemotherapy.

Sunvozertinib is the only targeted oral treatment for non–small cell lung cancer with EGFR exon 20 insertion mutations. | Image credit: Saiful52 - stock.adobe.com

NSCLC is the most common type of cancer, occurring when cells change and grow out of control in the lungs; these cells also are larger cancer cells that grow slower and may not cause immediate symptom.² Approximately 80% to 85% of all lung cancers are diagnosed as NSCLC. Adenocarcinoma, large cell carcinoma, and squamous cell carcinoma are the 3 main types of NSCLC. Those who have symptoms of NSCLC often report chest pain, chronic cough, loss of appetite, shortness of breath, wheezing, and tiredness, among other symptoms.

Sunvozertinib is a treatment that has molecular structure targeting, which can target a number of EGFR mutations through oral reception.¹ The medication is an irreversible EGFR inhibitor and was previously given a breakthrough therapy designation and priority review by the FDA; China had also given accelerated approval in 2023.

This approval was based on the WU-KONG1 Part B study (NCT03974022). The participants of the study had relapsed or refractory NSCLC with EGFR exon 20 insertion mutations and the results were presented at the 2024 American Society of Clinical Oncology Annual Meeting. The primary end point was to assess the antitumor efficacy of sunvozertinib in those with pretreated NSCLC.³

There were 107 patients who were included in the study who received 300 mg of sunvozertinib per day. A total of 57.9% of the participants were Asian, 48.6% had prior onco-immunotherapy, 25.2% had baseline brain metastasis, and 13.1% had EGFR tyrosine kinase inhibitor treatment. The objective response rate was 53.3%, and 66.7% of participants were still responding after a median follow-up of 7 months. Asians and non-Asians had comparable antitumor efficacy and prior anticancer therapies did not affect antitumor efficacy. The treatment was found to be safe overall.

In results that were presented at the 2023 European Society for Medical Oncology Annual Meeting, sunvozertinib was found to have an objective response rate of 78.6% and median progression-free survival of 12.4 months.¹

"Research findings from WU-KONG1B have demonstrated Zegfrovy's significant therapeutic effects with consistent efficacy across both Asian and non-Asian patient populations. Its convenient once-daily oral dosing substantially improves administration convenience and patient adherence, which is an increasingly critical factor as lung cancer care shifts toward chronic disease management. The US approval of Zegfrovy marks a landmark in scientific advancement and represents a meaningful milestone in addressing the long-standing unmet medical needs of this underserved patient population,” said Pasi A. Jänne, MD, PhD, Dana-Farber Cancer Institute of Harvard Medical School and lead principal investigator of WU-KONG1B, in a statement.¹

The FDA also approved the Thermo Fisher Scientific’s Oncomine Dx Express Test as a companion diagnostic for sunvozertinib to perform next-generation sequencing, which can help to identify patients with EGFR exon 20 insertion mutations and can deliver results of the sequencing in 24 hours. Between the 2 approvals, patients with NSCLC can look toward new methods of treatment that can address their NSCLC diagnosis as well as the mutations that defined the cancer diagnosis.

References

1. Dizal’s Zegfrovy (sunvozertinib) receives FDA accelerated approval as the only targeted oral treatment for non-small cell lung cancer with EGFR exon 20 insertion mutations. News release. Dizal. July 2, 2025. Accessed July 7, 2025. https://www.prnewswire.com/news-releases/dizals-zegfrovy-sunvozertinib-receives-fda-accelerated-approval-as-the-only-targeted-oral-treatment-for-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations-302497351.html

2. Non-small cell lung cancer. Cleveland Clinic. Updated January 16, 2025. Accessed July 7, 2025. https://my.clevelandclinic.org/health/diseases/6203-non-small-cell-lung-cancer

3. Doucet L, Greillier L, Planchard D, et al. 1260p efficacy and safety of sunvozertinib in prior platinum treated NSCLC patients with EGFR exon 20 insertion mutations: primary analysis from the multinational WU-KONG1B pivotal study. J Ann Oncol. 2024;35(2):S807-S808. doi:10.1016/j.annonc.2024.08.1317