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Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the US Food and Drug Administration (FDA) has accepted and granted priority review to the company’s New Drug Application (NDA) for sunvozertinib, an oral EGFR inhibitor for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
The FDA grants priority review to drugs that, if approved, would be significant improvements in the safety or effectiveness over existing treatment for a serious disease. This decision follows the FDA’s earlier Breakthrough Therapy Designations for Sunvozertinib in treatment naïve and relapsed or refractory settings. Currently, no small molecule drug has been approved in the US or Europe to treat this serious disease.
The NDA submission is supported by efficacy and safety results from the multinational pivotal WU-KONG1 Part B study, evaluating sunvozertinib in relapsed or refractory NSCLC patients with EGFR exon20ins from Asia, Europe, North America, and South America. These data, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated statistically significant clinical benefits.
“Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options,” said Xiaolin Zhang, PhD, CEO of Dizal. “Sunvozertinib’s Priority Review designation marks an important regulatory milestone in Dizal’s efforts to address unmet medical needs worldwide. The results from the WU-KONG1 Part B study are promising. If approved, sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins.”
In 2023, Sunvozertinib was granted accelerated approval by the National Medical Products Administration (NMPA) of China, making it the world’s first and only oral treatment for NSCLC patients with EGFR exon20ins.
Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.
Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.
Two global pivotal studies are ongoing in = 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.
Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.
Dizal is a biopharmaceutical company, dedicated to the discovery, development, and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases.
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