/ -- AbbVie (NYSE: ABBV) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA

/ -- 艾伯维（AbbVie，纽约证券交易所代码：ABBV）宣布已向美国食品药品监督管理局（FDA）提交了一份补充新药申请（sNDA），用于固定疗程、全口服的VENCLEXTA组合方案。

(venetoclax) and acalabrutinib in previously untreated patients with CLL, offering CLL patients another VENCLEXTA combination regimen with the potential for time-limited treatment.

（维奈托克）和阿卡替尼联合用于既往未接受治疗的CLL患者，为CLL患者提供了另一种具有限时治疗潜力的维奈托克联合方案。

The submission is based on the positive results from the Phase 3 AMPLIFY trial.

该提交基于 3 期 AMPLIFY 试验的积极结果。

The combination regimen of VENCLEXTA and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.

维奈托克与阿卡替尼联合方案相比标准化学免疫疗法，在既往未经治疗的CLL患者中改善了无进展生存期（PFS）。

'This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care,' said .

“这项FDA提交标志着CLL治疗的一个里程碑，有望批准首个口服组合方案——VENCLEXTA与acalabrutinib联合用于未经治疗的慢性血癌患者。这种新的固定治疗持续时间方法如果获得批准，可能使患者有机会暂停治疗，并且可能改变前线CLL护理的实践。”

Svetlana Kobina

斯维特兰娜·科比纳

, vice president, global medical affairs, oncology, AbbVie.

，副总裁，全球医学事务，肿瘤学，艾伯维。

About the AMPLIFY Study

关于AMPLIFY研究

AMPLIFY is an AstraZeneca-sponsored, global, multi-center Phase 3 trial evaluating VENCLEXTA plus acalabrutinib alone or combined with obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without del(17p) or TP53 mutation.

AMPLIFY 是一项由阿斯利康赞助的全球多中心 III 期临床试验，评估 VENCLEXTA 联合 acalabrutinib 单独使用或与 obinutuzumab 联用，对比化学免疫疗法，在既往未接受治疗且不携带 del(17p) 或 TP53 突变的 CLL 患者中的效果。

Data presented at the 2024 American Society of Hematology Annual Meeting showed that the fixed-duration combination regimen of VENCLEXTA and acalabrutinib reduced the risk of disease progression or death by 35% vs chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.004). The safety profile of the VENCLEXTA and acalabrutinib combination regimen is consistent with the known safety profile of each individual therapy alone.

2024年美国血液学会年会上提供的数据显示，VENCLEXTA与acalabrutinib的固定疗程联合方案相较于化学免疫疗法，可将疾病进展或死亡风险降低35%（HR 0.65；95% CI：0.49-0.87；p=0.004）。VENCLEXTA与acalabrutinib联合方案的安全性特征与其各单药治疗已知的安全性特征一致。

The most common adverse events in any grade were neutropenia, hemorrhage, and COVID-19 in patients administered VENCLEXTA plus acalabrutinib. The most frequent Grade 3 or higher adverse event was neutropenia seen in 26.8% of patients. Among events of clinical interest, low rates of tumor lysis syndrome were observed with events of any grade seen in 0.3% of patients treated with VENCLEXTA plus acalabrutinib compared to 3.1% for patients treated with chemoimmunotherapy.

任何级别的最常见不良事件是接受VENCLEXTA加acalabrutinib治疗的患者出现中性粒细胞减少、出血和COVID-19。最常见的3级或更高级别的不良事件是中性粒细胞减少，有26.8%的患者出现此症状。在临床关注的事件中，观察到低发生率的肿瘤溶解综合征，在接受VENCLEXTA加acalabrutinib治疗的患者中有0.3%出现任何级别的事件，而接受化疗免疫治疗的患者这一比例为3.1%。

No new safety signals were observed in the AMPLIFY study..

在AMPLIFY研究中未观察到新的安全信号。

About VENCLEXTA

关于VENCLEXTA

VENCLEXTA (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis..

VENCLEXTA（维奈托克）是一种首创的药物，可选择性结合并抑制B细胞淋巴瘤-2（BCL-2）蛋白。在某些血液癌症中，BCL-2阻止癌细胞经历其自然死亡或自我毁灭的过程，称为细胞凋亡。VENCLEXTA靶向BCL-2蛋白，并帮助恢复细胞凋亡的过程。

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers.

VENCLEXTA由AbbVie和罗氏共同开发。在美国，该药物由AbbVie与罗氏集团成员Genentech共同商业化，而在美国以外则由AbbVie负责。两家公司共同致力于BCL-2研究，并在多种血液癌及其他癌症的临床试验中对维奈托克进行研究。

Venetoclax is approved in more than 80 countries, including the U.S..

维奈托克已在包括美国在内的 80 多个国家获得批准。