Primary-source record

Decision-gradeFDA approval

AstraZeneca ZEGFROVY (sunvozertinib) receives FDA accelerated approval for EGFR exon 20 insertion NSCLC

FDA granted accelerated approval of ZEGFROVY (sunvozertinib) for adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy. Approval based on WU-KONG1B trial showing 46% ORR and 11.1-month median DoR; continued approval contingent on confirmatory trial. Product is now commercially available in the US as the only approved oral single-agent targeted therapy in this setting.

Key facts

Filed
Oct 22, 2026, 12:10 PM
Event
FDA approval
Direction
Positive
Confidence
Sourced
ORR
46% (95% CI 35-57)
DOR >=6mo
72%
median DOR
11.1 months (95% CI 8.2, NE)

Source excerpt

ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations Only approved oral, single agent, targeted therapy for these patients following platinum-based chemotherapy Launch expands AstraZeneca’s commitment to addressing substantial unmet need across the spectrum of EGFR-mutated lung cancer with a proven portfolio of medicines targeting EGFR mutations AstraZeneca today announced the US availability of ZEGFROVY ® (sunvozertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy. 1 The US Food and Drug Administration granted accelerated approval to ZEGFROVY based on results from the WU-KONG1B trial. 2 In the open-label, dose randomization clinical trial, ZEGFROVY demonstrated a confirmed overall response rate of 46% (n=85; 95% confidence interval [CI] 35, 57) and a median duration of response of 11.1 months in those responders (n=39; 9

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