Dizal’s ZEGFROVY® Receives FDA Accelerated Approval as First Oral Therapy for EGFR Exon20ins NSCLC
Thursday, July 03, 2025
Dizal has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for ZEGFROVY® (sunvozertinib) to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations.
EGFR exon 20 insertion mutations are a rare and complex form of genetic alteration found in certain NSCLC patients. These mutations affect the epidermal growth factor receptor (EGFR) gene, which helps regulate cell growth. Exon20ins mutations account for the third most common type of EGFR mutation in NSCLC.
They are typically more difficult to treat than other EGFR mutations due to their structural diversity and resistance to standard EGFR inhibitors. As a result, patients often face limited treatment choices and a poorer prognosis. New targeted therapies like ZEGFROVY aim to provide more effective and convenient treatment options for this underserved population.
This applies to patients whose disease has progressed following platinum-based chemotherapy and is confirmed through an FDA-approved test.
ZEGFROVY is now the first approved oral targeted treatment for this patient group. The approval follows Priority Review and Breakthrough Therapy Designation by the FDA. It is based on results from the WU-KONG1 Part B study, which showed strong response rates and sustained benefit. Continued approval may depend on further confirmatory trial data.
ZEGFROVY is taken once daily and works as an irreversible EGFR inhibitor. It targets a broad range of EGFR mutations while sparing normal EGFR, helping to reduce side effects. The FDA approval also includes the use of a companion diagnostic test, developed by Thermo Fisher Scientific, which uses next-generation sequencing (NGS) to rapidly identify patients with the required genetic mutation.
The treatment was earlier approved in China and is being further evaluated in the global phase III WU-KONG28 trial. Interim data have shown high response rates and a favourable safety profile, indicating its potential use as a first-line therapy.
Source: dizalpharma.com
