On July 2, 2025, the FDA granted accelerated approval to Zegfrovy (sunvozertinib) for people facing locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 20 insertion mutation—a rare and challenging subtype. This new approval is for those who have already been treated with chemotherapy and need additional options.
The approval was based on the WU-KONG1B study, which showed that Zegfrovy not only helped shrink tumors in patients with this mutation but also provided responses that lasted a meaningful amount of time. These results offer new hope to patients who have progressed after chemotherapy and may have limited treatment paths left.
Zegfrovy is part of a class of drugs known as tyrosine kinase inhibitors (TKIs), which target and block the abnormal EGFR protein that drives cancer growth. By doing so, it may help slow or stop tumor progression.
This is a meaningful step forward for patients and families navigating a difficult lung cancer diagnosis with fewer existing treatment options.
Read the FDA announcement
