US FDA Grants Priority Review to Dizal's Sunvozertinib NDA

Dizal, a biopharmaceutical firm dedicated to creating innovative therapies for cancer and immunological disorders, revealed that the U.S. Food and Drug Administration (FDA) has accepted and assigned priority review to the company's New Drug Application (NDA) for sunvozertinib, an oral EGFR inhibitor aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), identified through an FDA-approved test, who have experienced disease progression following platinum-based chemotherapy.

The FDA offers priority review to medications that, upon approval, would be major enhancements in safety or efficacy compared to current treatments for a severe illness. This choice comes after the FDA's previous Breakthrough Therapy Designations for Sunvozertinib in both treatment-naïve and relapsed or refractory cases. At present, no small molecule medication has been authorized in the U.S. or Europe for addressing this severe illness.

"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."