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

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 ...

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

Matt Galsky, MD, discusses the phase 3 NIAGARA trial that led to the recent FDA approval of durvalumab in muscle-invasive ...

The Food and Drug Administration (FDA) has approved Imfinzi ® (durvalumab), in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent Imfinzi as adjuvant ...

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。

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s IMFINZI ® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as adjuvant monotherapy after ...

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 ...

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings.

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