Dizal Gains FDA Nod for Oral Therapy to Treat NSCLC with EGFR Exon 20 Insertion Mutations
This regulatory decision, which has been accepted under an accelerated basis, makes sunvozertinib the only approved targeted oral treatment for NSCLC with EGFR exon20ins.
Biopharmaceutical company, Dizal, has announced, in a July 3, 2025 press release (1), that the FDA has granted an accelerated approval for its oral therapy, sunvozertinib (ZEGFROVY). Through this regulatory approval, sunvozertinib is indicated as a treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations.
Sunvozertinib is an oral, irreversible, EGFR inhibitor that received priority review (2) and breakthrough designation from the FDA. This latest regulatory decision is under an accelerated approval basis, which means that continued approval for the specified indication will be contingent upon verification and description of clinical benefit in a confirmatory trial.
“We are proud to have developed ZEGFROVY, a first-in-class oral therapy that offers a more effective treatment option with enhanced safety and ease of administration for NSCLC patients with EGFR exon20ins,” said Dr. Xiaolin Zhang, CEO of Dizal, in the company press release (1). “The accelerated approval of ZEGFROVY marks a significant milestone that underscores our commitment to developing groundbreaking new medicines for patients with high unmet medical needs around the world.”
FDA’s decision was supported by data from a multinational pivotal study, WU-KONG1 Part B (WU-KONG1B), that investigated the efficacy and safety of sunvozertinib in relapsed or refractory NSCLC with EGFR exon20ins. The study met the primary endpoints, with sunvozertinib achieving a best objective response rate of 53.3% (3).
“As the world's only approved targeted oral therapy for EGFR exon20ins NSCLC, ZEGFROVY has expanded the treatment paradigm in this therapeutic area that has long lacked convenient and effective treatment options,” added Pasi A. Jänne, MD, PhD, Dana-Farber Cancer Institute of Harvard Medical School and lead principal investigator of WU-KONG1B, in the press release (1). “Research findings from WU-KONG1B have demonstrated ZEGFROVY’s significant therapeutic effects with consistent efficacy across both Asian and non-Asian patient populations. [The] convenient once-daily oral dosing substantially improves administration convenience and patient adherence, which is an increasingly critical factor as lung cancer care shifts toward chronic disease management. The U.S. approval of ZEGFROVY marks a landmark in scientific advancement and represents a meaningful milestone in addressing the long-standing unmet medical needs of this underserved patient population.”
“ZEGFROVY has demonstrated breakthrough therapeutic value in the treatment of EGFR exon20ins NSCLC, as shown in a rigorous multinational clinical trial. Its potent antitumor activity, manageable safety profile, and convenient oral administration position it as an optimal treatment option in clinical practice,” said Prof. James Chih-Hsin Yang, MD, PhD, National Taiwan University Cancer Center Hospital and the Co-lead principal investigator of WU-KONG1B, in the press release (1). “The approval of ZEGFROVY in major global markets not only offers new hope for patients, but also reinforces our commitment to patient-centered research and the continued advancement of precision medicine in lung cancer."
References
Dizal. Dizal’s ZEGFROVY (Sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Press Release, July 3, 2025.
Dizal. U.S. FDA Granted Priority Review to Dizal’s Sunvozertinib New Drug Application. Press Release, Jan. 7, 2025.
Dizal. Sunvozertinib’s Global Pivotal WU-KONG1B Study Meets Primary Endpoint in Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Press Release, June, 2, 2024.