Posted by Michael Wonder on 03 Jul 2025
FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
2 July 2025 - Today, the FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal) for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.
Today, FDA also approved the Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting EGFR exon 20 insertion mutations in patients with non-small cell lung cancer who may be eligible for treatment with Zegfrovy.
