As reported on Business Wire, AstraZeneca has finalized its previously announced licensing agreement with Dizal Pharmaceutical, gaining exclusive worldwide rights to develop and market ZEGFROVY (sunvozertinib), an oral, irreversible epidermal growth factor receptor (EGFR) inhibitor for lung cancer.
The therapy is currently approved in both the United States and China as a second-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations. This patient population faces particularly poor outcomes, with real-world data showing five-year overall survival rates that can be as low as 8%, highlighting the need for more effective targeted therapies.
ZEGFROVY is already available in China for eligible patients, while AstraZeneca plans to introduce the drug in the United States during the fourth quarter of 2026. The treatment has also been incorporated into the National Comprehensive Cancer Network (NCCN) Guidelines for NSCLC, where it is recommended as a subsequent therapy option for patients whose tumors harbor EGFR exon 20 insertion mutations.
Beyond its approved second-line indication, the drug may soon expand into earlier treatment settings. The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application seeking approval for first-line use in patients with EGFR exon 20 insertion mutation-positive NSCLC. The filing is based on findings from the global Phase III WU-KONG28 trial, which demonstrated positive results for sunvozertinib in previously untreated patients.
The WU-KONG28 data were highlighted in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and were simultaneously published in The New England Journal of Medicine. Regulatory momentum is also building in China, where an application for first-line approval has been submitted to the Center for Drug Evaluation.
Recognizing the potential of the therapy in this setting, both the FDA and China’s regulatory authorities have granted Breakthrough Therapy Designation for first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations.
With the acquisition of global commercialization rights and ongoing regulatory reviews, AstraZeneca is positioning ZEGFROVY as a potential new treatment option across multiple lines of therapy for a difficult-to-treat subset of lung cancer patients.
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