本次新适应症的获批是基于多中心、全球 III 期试验 NIAGARA 的结果。该试验旨在评估根治性膀胱切除术前后使用度伐利尤单抗对 MIBC 患者进行围手术期治疗的效果。在试验中，1063 名患者随机接受度伐利尤单抗加新辅助化疗，然后进行膀胱切除术，或者在膀胱切除术前单独接受新辅助化疗，术后无需进一步治疗。研究的双重主要终点是无事件生存期（EFS）和膀胱切除时的病理完全缓解 (pCR)。

Investing.com — 美国食品药品监督管理局（FDA）已批准阿斯利康制药的IMFINZI®（durvalumab）联合吉西他滨和顺铂用于成人肌肉浸润性膀胱癌（MIBC）的新辅助治疗，随后在手术后使用IMFINZI单药治疗。这一获得优先审查资格的批准基于第三阶段NIAGARA试验结果。市值达2250亿美元的阿斯利康制药被 InvestingPro ...

欧盟委员会的决定基于AEGEAN III期临床试验结果，该试验显示与单独使用新辅助化疗相比，疾病复发、进展或死亡风险降低了32%。试验结果已发表在《新英格兰医学杂志》上。这一进展进一步巩固了阿斯利康的强劲表现，该公司报告在过去十二个月内收入同比增长18%，达到541亿美元。

An exploratory analysis shows a reduction in extrathoracic metastases and prolonged time to progression or death due to any ...

Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in ...

David Spigel, MD, discusses the significant benefits of durvalumab as consolidation therapy following standard ...

2 Cheng Y, et al. Durvalumab after chemoradiotherapy in limited-stage small-cell lung cancer. N Engl J Med. 2024;391(14):1313-1327. 3 National Cancer Institute. NCI dictionary - small cell lung ...

neoadjuvant chemotherapy alone WILMINGTON, Del., March 31, 2025--(BUSINESS WIRE)--AstraZeneca’s IMFINZI ® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment ...

AstraZeneca‘s IMFINZI® (durvalumab) has gained FDA approval for use in adult patients with muscle-invasive bladder cancer ...

Matt Galsky, MD, delved into the recent approval of a perioperative durvalumab regimen in muscle-invasive bladder cancer.

Approval was based on improved survival outcomes vs platinum-based chemotherapy as demonstrated in the phase 3 NIAGARA study.

AstraZeneca’s IMFINZI® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as adjuvant monotherapy after radical cystectomy (surgery to remove the ...