AstraZeneca (NYSE:AZN) today announced the successful completion of the previously announced exclusive license agreement with Dizal Pharmaceutical Co., Ltd 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 commercialize ZEGFROVY.
ZEGFROVY is approved in the US and China for the 2nd-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 U.S. 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. See NCCN Guidelines® for detailed recommendations.
A supplemental New Drug Application for approval of ZEGFROVY in the 1st-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global WU-KONG28 Phase III trial of ZEGFROVY in 1st-line NSCLC with EGFR exon 20 insertion mutations.
AZN shares grew 14 cents to $162.27.
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