Onco-Summaries: Daily Oncology Updates at a Glance
22/10/2026
AstraZeneca commercializes ZEGFROVY® following US FDA approval in EGFR exon 20 insertion NSCLC (Ref)
AstraZeneca announced the US availability of ZEGFROVY® (sunvozertinib; EGFR-TKI), a targeted therapy for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed following platinum-based chemotherapy
In Jul'25, the US FDA granted accelerated approval to ZEGFROVY based on results from the WU-KONG1B trial, which demonstrated an overall response rate (ORR) of 46% and a median duration of response (DoR) of 11.1 months
Sunvozertinib (ZEGFROVY®) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC
Additionally, a Supplemental New Drug Application for approval in the 1st-line setting, based on Phase III WU-KONG28 trial has been submitted to the US FDA and China’s Center for Drug Evaluation (CDE)
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