Dizal's ZEGFROVY® Gains FDA Approval for Targeted Lung Cancer Treatment

On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Dizal Pharmaceutical's ZEGFROVY® (sunvozertinib), marking it as the sole targeted oral treatment for adults with advanced non-small cell lung cancer (NSCLC) characterized by epidermal growth factor receptor (EGFR) exon 20 insertion mutations. This milestone is pivotal as it addresses a significant gap in treatment options for patients who have progressed after platinum-based chemotherapy.

ZEGFROVY’s approval follows a thorough review process, including Priority Review and Breakthrough Therapy Designation, recognizing the urgent need for effective treatments in this patient population. According to Dr. Xiaolin Zhang, CEO of Dizal, “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.”

The FDA's decision is backed by results from the multinational pivotal WU-KONG1 Part B trial, where ZEGFROVY exhibited statistically significant efficacy and a favorable safety profile. Results from this study were recently published in the Journal of Clinical Oncology, with findings presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial aimed to evaluate the drug's safety and efficacy in patients with relapsed or refractory NSCLC, demonstrating substantial benefits that could transform the therapeutic landscape for this challenging condition.

Dr. Pasi A. Jänne, MD, PhD, a leading figure at Dana-Farber Cancer Institute and principal investigator of the WU-KONG1B study, highlighted that ZEGFROVY has shown significant therapeutic effects across diverse patient demographics, including both Asian and non-Asian populations, and its once-daily dosing regimen enhances patient adherence.

In the context of lung cancer treatment, EGFR exon20 insertion mutations represent a particularly difficult challenge due to their distinct structural configurations and broad variability. According to Prof. Mengzhao Wang, MD, PhD, from Peking Union Medical College Hospital, “Patients with EGFR exon20ins face a poor prognosis and limited treatment options; therefore, ZEGFROVY’s approval is a crucial advancement.”

The FDA's approval also includes the endorsement of Thermo Fisher Scientific's Oncomine™ Dx Express Test as a next-generation sequencing companion diagnostic, aimed at identifying NSCLC patients with these specific mutations. This testing technology is pivotal for timely and precise treatment decisions, enabling rapid mutation detection in tumor samples.

Dizal is not resting on its laurels; the company has completed enrollment for its phase III WU-KONG28 study, which compares ZEGFROVY against platinum-based doublet chemotherapy in treatment-naïve NSCLC patients with EGFR exon20 insertion mutations across 16 countries. Preliminary results from earlier studies indicated a remarkable objective response rate of 78.6% and a median progression-free survival of 12.4 months, suggesting that ZEGFROVY could become a standard first-line treatment option.

The implications of ZEGFROVY's approval extend beyond immediate patient care; it signifies a broader movement towards personalized medicine in oncology, particularly in addressing the unmet needs of patients suffering from complex genetic profiles. As Dizal continues to pursue further research and development, the future looks promising for those affected by this challenging form of lung cancer.

In summary, ZEGFROVY’s FDA approval represents a landmark moment in the treatment of NSCLC with EGFR exon20 insertion mutations, potentially transforming the lives of patients who previously had limited options. With ongoing studies and expanding global approvals, Dizal is poised to lead advancements in precision cancer therapy.