FDA Prioritizes Review of Dizal's Sunvozertinib NDA

SHANGHAI, Jan. 7, 2025 /PRNewswire/ -- Dizal, a biopharmaceutical enterprise known for creating innovative treatments for cancer and immune diseases, has announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for sunvozertinib. This acceptance comes with a priority review status, indicating the drug's potential to significantly enhance treatment effectiveness or safety for non-small cell lung cancer (NSCLC) characterized by specific genetic mutations.

Sunvozertinib is an oral EGFR inhibitor designed for patients with locally advanced or metastatic NSCLC, whose cancer features EGFR exon 20 insertion mutations (exon20ins). These mutations are identified through an FDA-approved test, and the drug aims to help those whose disease has worsened despite prior platinum-based chemotherapy treatments. The priority review granted by the FDA underscores its potential as a significant improvement over existing therapies for a serious condition.

Previously, the FDA had also provided Breakthrough Therapy Designations for sunvozertinib in both treatment-naïve and relapsed or refractory cases, highlighting its promise in these challenging scenarios. Notably, there are currently no approved small molecule drugs in the U.S. or Europe specifically targeting this serious disease, further underscoring the significance of this development.

The NDA submission for sunvozertinib is supported by data showcasing its effectiveness and safety, gathered from the pivotal WU-KONG1 Part B study. This study involved relapsed or refractory NSCLC patients from diverse regions, including Asia, Europe, and the Americas, and the results were shared at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings highlighted significant clinical benefits, marking a hopeful step forward for patients with limited treatment options.

Xiaolin Zhang, PhD, CEO of Dizal, emphasized the dire prognosis faced by patients with EGFR exon20ins NSCLC and the limited available therapies. He noted that the Priority Review designation is a crucial regulatory achievement, signaling progress in Dizal’s mission to meet unmet global medical needs. If sunvozertinib receives approval, it would provide a convenient and effective single-drug oral treatment option for these patients.

In 2023, sunvozertinib achieved accelerated approval from the National Medical Products Administration (NMPA) of China, making it the first oral treatment of its kind for NSCLC patients with EGFR exon20ins. The drug, known scientifically as DZD9008, is an irreversible EGFR inhibitor crafted by Dizal’s researchers, targeting a broad range of EGFR mutations while maintaining selectivity for the wild-type EGFR.

August 2023 saw sunvozertinib receiving NMPA approval for treating advanced NSCLC in patients with EGFR exon20ins who had previously undergone platinum-based chemotherapy. This approval was rooted in the pivotal WU-KONG6 study, which evaluated sunvozertinib’s efficacy in this patient population. Additionally, sunvozertinib has shown promising anti-tumor activity in NSCLC patients with various EGFR mutations, including sensitizing, T790M, and uncommon mutations like G719X and L861Q, as well as HER2 exon20ins.

In clinical settings, sunvozertinib has demonstrated a manageable and well-tolerated safety profile, with most treatment-related adverse events being mild to moderate in nature. Two major global studies are ongoing: WU-KONG1 Part B, focusing on patients who have undergone at least two treatments, and WU-KONG28, aimed at first-line treatment settings for NSCLC patients with EGFR exon20ins.

Sunvozertinib's pre-clinical and clinical studies have been featured in esteemed scientific journals such as Cancer Discovery and The Lancet Respiratory Medicine, underscoring the drug’s scientific and clinical significance.

Dizal remains devoted to the discovery, development, and commercialization of pioneering therapeutics for cancer and immunological disorders, striving to bring first-in-class and innovative treatments to address critical medical needs on a global scale.