智通财经APP获悉，3月31日，阿斯利康(AZN.US)宣布，FDA已批准度伐利尤单抗 (Durvalumab) 一新适应症上市，具体为：度伐利尤单抗联合吉西他滨和顺铂作为新辅助治疗，随后度伐利尤单抗作为根治性膀胱切除术后的辅助单药治疗，用于治疗肌层浸润性膀胱癌 (MIBC ...

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 ...

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 ...

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

Investing.com — 阿斯利康制药(LSE/STO/Nasdaq: AZN)，这家市值达2230亿美元、根据InvestingPro数据显示毛利率高达82%的制药巨头，今日 ...

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

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 ...

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 ...

The FDA has approved neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab after radical cystectomy in MIBC.