Dizal’s Sunvozertinib Receives U.S. FDA Approval for Non-Small Cell Lung Cancer (NSCLC) Treatment
Wednesday, January 08, 2025
Dizal has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sunvozertinib, an oral therapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
Sunvozertinib, also known as DZD9008, is an irreversible EGFR inhibitor designed to selectively target a wide range of EGFR mutations while sparing wild-type EGFR.
It has also demonstrated promising results in NSCLC patients with other EGFR mutations, including sensitising, T790M, and uncommon variants like G719X and L861Q, as well as HER2 exon20ins.
The treatment has shown a manageable safety profile, with most side effects being mild or moderate in nature.
The treatment targets patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed following platinum-based chemotherapy, as confirmed by an FDA-approved test.
The FDA has granted priority review to the application, a status reserved for drugs that may significantly improve treatment outcomes for serious conditions.
This follows earlier Breakthrough Therapy Designations awarded to sunvozertinib for its potential use in treatment-naïve and relapsed or refractory cases of NSCLC. Currently, no small molecule drugs are approved in the U.S. or Europe for this specific indication, underscoring its importance.
The submission is based on findings from the WU-KONG1 Part B study, a multinational trial assessing the safety and efficacy of sunvozertinib in relapsed or refractory NSCLC patients with EGFR exon20ins mutations.
The study, conducted across Asia, Europe, North America, and South America, demonstrated statistically significant clinical benefits, as presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
In 2023, sunvozertinib received accelerated approval from China’s National Medical Products Administration (NMPA), becoming the first oral treatment globally for NSCLC patients with EGFR exon20ins mutations.
This approval was supported by data from the WU-KONG6 study, which focused on patients pre-treated with platinum-based chemotherapy.
If approved, sunvozertinib could provide a novel, oral treatment option for patients with advanced NSCLC, addressing a critical unmet medical need.
Source: dizalpharma.com
