Dizal has announced a landmark achievement with the U.S. Food and Drug Administration (FDA) granting Accelerated Approval to its groundbreaking drug, ZEGFROVY® (sunvozertinib). This approval is particularly significant as ZEGFROVY is now the only approved targeted oral treatment available for adult patients battling locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins), specifically for those whose disease has progressed after platinum-based chemotherapy. This designation highlights a critical unmet need in this patient population, who previously faced extremely limited and often ineffective treatment options.

The FDA's decision followed a Priority Review and was supported by robust data from the multinational pivotal WU-KONG1 Part B study. This trial demonstrated statistically significant and clinically meaningful benefits, showcasing ZEGFROVY's ability to elicit impressive overall response rates and a durable duration of response. Dr. Xiaolin Zhang, CEO of Dizal, underscored the importance of this approval, noting that ZEGFROVY is a "first-in-class oral therapy" designed to offer not only greater efficacy but also enhanced safety and ease of administration.

What makes ZEGFROVY truly innovative is its unique molecular structure. It's an oral, irreversible EGFR inhibitor engineered to target a wide spectrum of EGFR mutations while maintaining selectivity for wild-type EGFR. This precision minimizes off-target effects, contributing to its manageable safety profile. The drug has already received accelerated approval in China, and its U.S. approval further solidifies its global impact.

Leading experts, including Dr. Pasi A. Jänne of Dana-Farber Cancer Institute, emphasized that ZEGFROVY fundamentally expands the treatment paradigm for EGFR exon20ins NSCLC. Its convenient once-daily oral dosing significantly improves patient adherence, a crucial factor as lung cancer increasingly becomes a chronic disease managed over time. Furthermore, the consistent efficacy observed across both Asian and non-Asian patient populations in the WU-KONG1B study reinforces its broad applicability.

To ensure precise patient identification, the FDA concurrently approved Thermo Fisher Scientific’s Oncomine™ Dx Express Test as a companion diagnostic (CDx). This next-generation sequencing (NGS) test enables rapid and accurate detection of the specific EGFR Exon20 insertions, allowing for more timely and informed treatment decisions.

Looking ahead, Dizal has already completed enrollment for its multinational Phase III pivotal WU-KONG28 study, which is evaluating ZEGFROVY as a first-line treatment for treatment-naïve NSCLC patients with EGFR exon20ins. Early data from this study presented at ESMO 2023 showed a promising confirmed objective response rate (ORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months, further suggesting ZEGFROVY's strong potential to redefine initial treatment strategies for this challenging cancer.