FDA Approval Alert: The Need-to-Know | Sunvozertinib in EGFR Exon 20+ NSCLC

In July 2025, the FDA granted accelerated approval to sunvozertinib as a treatment for adults with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations as detected with an FDA-approved test following progression on or after platinum-containing chemotherapy.

Data from the phase 1/2 WU-KONG1 study support the accelerated approval of sunvozertinib in this population.
Sunvozertinib Earns FDA Accelerated Approval in EGFR Exon 20+ NSCLC
Article
Jul 2, 2025 9:18 PM
Data from the phase 1/2 WU-KONG1 study support the accelerated approval of sunvozertinib in this population.