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 how tumors responded to this treatment in 85 patients. The data showed the cancer shrank or disappeared with sunvozertinib treatment in 46% of patients (overall response rate) and this benefit lasted approximately 11 months (duration of response).
It’s important to note that this is an accelerated approval intended to bring treatments to patients as quickly as possible. This drug continues to be tested in clinical trials.
For more details, including common side effects, please see this information announcing the drug approval.