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JULY 2, 2025

FDA Grants Accelerated Approval to Zegfrovy for Some Patients With Metastatic NSCLC

The FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal [Jiangsu] Pharmaceutical) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) 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.

The FDA also approved the Oncomine Dx Express Test (Life Technologies Corp.) as a companion diagnostic device to aid in detecting