New Treatment for Patients with Metastatic NSCLC with EGFR Exon 20 Insertion Mutations
On July 2, 2025, the US Food and Drug Administration (FDA) announced the accelerated approval of sunvozertinib (Zegfrovy®) to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins). These mutations are found in approximately 2% of patients with NSCLC. Sunvozertinib is a tyrosine kinase inhibitor (TKI) that targets EGFR exon20ins in patients whose tumors have started to grow again after chemotherapy. The FDA approval is supported by data from a phase 2 clinical trial, WU-KONG1B, a multinational trial, that studied