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news.The US Food and Drug Administration (FDA) has granted priority review to Dizal's new drug application (NDA) for sunvozertinib aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.
Currently, two global pivotal studies are underway for the therapy. Credit: jarmoluk on Pixabay.
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The decision is intended for individuals with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as assessed by an FDA-approved test. This marks offering a new potential therapy for a serious disease that currently lacks approved small molecule treatments in the US and Europe.
Sunvozertinib’s NDA is backed by data from the multinational pivotal WU-KONG1 Part B study, that assessed the therapy’s safety and efficacy in relapsed or refractory NSCLC in subjects with this specific mutation across Asia, North America, South America, and Europe.
Dizal CEO Xiaolin Zhang 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.”
Discovered by the company’s scientists, sunvozertinib is a selective irreversible EGFR inhibitor targeting a broad range of EGFR mutations. It received approval from the National Medical Products Administration (NMPA) in August 2023.
The therapy has also exhibited ‘encouraging anti-tumour activity’ in NSCLC subjects with various EGFR sensitising, T790M, and uncommon mutations, including HER2 exon20ins.
Clinically, it has demonstrated a ‘manageable’ safety profile.
Currently, two global pivotal studies are underway for the therapy. The WU-KONG1 Part B study is focused on subjects who have undergone a minimum of one previous line of therapy, while the WU-KONG28 study is assessing it in a first-line setting for NSCLC subjects with EGFR exon20ins.
