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).

Dizal宣布，美国食品和药物管理局（FDA）已接受舒伐泽替尼的新药申请（NDA），舒伐泽替尼是一种治疗局部晚期或转移性非小细胞肺癌（NSCLC）的口服疗法。

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.

Sunvozertinib，也称为DZD9008，是一种不可逆的EGFR抑制剂，旨在选择性靶向多种EGFR突变，同时保留野生型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.

它在具有其他EGFR突变的NSCLC患者中也显示出有希望的结果，包括致敏，T790M和罕见变体，如G719X和L861Q，以及HER2外显子20ins。

The treatment has shown a manageable safety profile, with most side effects being mild or moderate in nature.

该治疗显示出可控的安全性，大多数副作用本质上是轻度或中度的。

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.

该治疗针对表皮生长因子受体（EGFR）外显子20插入突变的患者，其疾病在铂类化疗后进展，这已通过FDA批准的测试得到证实。

The FDA has granted priority review to the application, a status reserved for drugs that may significantly improve treatment outcomes for serious conditions.

美国食品和药物管理局（FDA）已批准对该申请进行优先审查，该状态保留给可能显着改善严重疾病治疗效果的药物。

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.

此前，sunvozertinib因其在治疗初治和复发或难治性NSCLC病例中的潜在用途而被授予早期突破性治疗称号。目前，美国或欧洲尚未批准用于这种特定适应症的小分子药物，这突显了其重要性。

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.

提交的材料是基于WU-KONG1 B部分研究的结果，该研究是一项多国试验，评估了sunvozertinib在EGFR exon20ins突变的复发或难治性NSCLC患者中的安全性和有效性。

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.

正如2024年美国临床肿瘤学会（ASCO）年会上所介绍的那样，这项在亚洲，欧洲，北美和南美进行的研究显示出统计学上显着的临床益处。

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.

2023年，sunvozertinib获得了中国国家医药产品管理局（NMPA）的加速批准，成为全球首例针对EGFR外显子20ins突变的NSCLC患者的口服治疗。

This approval was supported by data from the WU-KONG6 study, which focused on patients pre-treated with platinum-based chemotherapy.

WU-KONG6研究的数据支持了这一批准，该研究侧重于铂类化疗预处理的患者。

If approved, sunvozertinib could provide a novel, oral treatment option for patients with advanced NSCLC, addressing a critical unmet medical need.

如果获得批准，sunvozertinib可以为晚期非小细胞肺癌患者提供一种新颖的口服治疗选择，解决严重未满足的医疗需求。

Source: dizalpharma.com

来源：dizalpharma.com