AstraZeneca has started an exclusive licencing agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib), an oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer.
Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialise Zegfrovy.
Zegfrovy is approved in the US and China for the second-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8% underscoring the unmet need for new treatment options. Zegfrovy is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication.
Sunvozertinib (Zegfrovy) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC. It is recommended as a subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC.
A supplemental New Drug Application for approval of Zegfrovy in the first-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global phase 3 trial of Zegfrovy in first-line NSCLC with EGFR exon 20 insertion mutations.
Zegfrovy has also been submitted for approval in the first-line setting to China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to Zegfrovy in this setting.
