NEW YORK – Dizal Pharmaceutical said Tuesday that it has submitted a new drug application to the US Food and Drug Administration seeking approval for its EGFR inhibitor sunvozertinib in previously treated, advanced non-small cell lung cancer patients whose tumors harbor EGFR exon 20 insertion mutations.
The FDA has granted priority review to the application, which includes data from Part B of the Phase I/II WU-KONG1 clinical trial. This portion of the pivotal trial enrolled EGFR exon 20 insertion mutation-positive NSCLC patients from Asia, Europe, North America, and South America. The patients had received between one and three prior lines of systemic therapy and had to have documented EGFR exon 20 insertion mutations, as determined by a CLIA-certified laboratory or equivalent, or a sponsor-designated central laboratory.
Among 107 patients, the confirmed overall response rate was 44.9 percent and the median duration of response had not yet been reached, according to data presented at the 2024 American Society of Clinical Oncology annual meeting. The drug was well tolerated with a manageable safety profile.
In 2023, China's National Medical Products Administration (NMPA) granted accelerated approval to sunvozertinib for previously treated patients with EGFR exon 20 insertion mutations based on the WU-KONG6 study.
If the FDA approves the agent, it would mark the first commercially available agent specifically indicated for the subset of NSCLC patients with EGFR exon 20 insertion mutations.
Beyond WU-KONG1, Shanghai-based Dizal is also evaluating sunvozertinib in the first-line NSCLC treatment setting in the WU-KONG28 clinical trial.