Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, has 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.

It is 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.

Commenting on the development, Xiaolin Zhang, PhD, CEO of Dizal said, “Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options. 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.