What Was Approved?
On July 2, 2025, the FDA approved Zegfrovy (sunvozertinib) for adults with locally advanced or metastatic non-small cell lung cancer, or NSCLC, whose tumors have an EGFR exon 20 insertion mutation and whose disease has progressed on or after platinum-based chemotherapy.
An FDA-approved test is required to identify the qualifying mutation.
How Does Zegfrovy Work?
Zegfrovy is an oral EGFR tyrosine kinase inhibitor.
It targets abnormal EGFR signaling that can drive tumor growth in cancers with qualifying exon 20 insertion mutations.
Who Is Zegfrovy For?
Zegfrovy is not for every patient with NSCLC.
The approved population requires:
- Locally advanced or metastatic NSCLC
- A qualifying EGFR exon 20 insertion mutation
- Disease progression on or after platinum-based chemotherapy
Why Is Biomarker Testing Important?
Treatment depends on the exact molecular alteration in the tumor.
An EGFR mutation in general does not automatically mean that Zegfrovy is appropriate.
Bottom Line
Zegfrovy (sunvozertinib) is an FDA-approved targeted therapy for certain previously treated adults with EGFR exon 20 insertion-mutated advanced NSCLC.
Appropriate molecular testing is required before treatment.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.