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阿斯利康Durvalumab联合疗法获CDSCO批准,治疗肌层浸润性膀胱癌

AstraZeneca’s Durvalumab Combination Therapy Approved by CDSCO for Muscle-Invasive Bladder Cancer Treatment

GeneOnline 等信源发布 2025-07-15 14:07

可切换为仅中文


AstraZeneca has received approval from the Central Drugs Standard Control Organisation (CDSCO) for its treatment regimen targeting muscle-invasive bladder cancer (MIBC). The approved therapy involves the use of Durvalumab in combination with gemcitabine and cisplatin as a neoadjuvant treatment, followed by single-agent Durvalumab as an adjuvant treatment after radical cystectomy.

阿斯利康已获得中央药物标准控制组织 (CDSCO) 的批准,用于其针对肌层浸润性膀胱癌 (MIBC) 的治疗方案。获批的疗法包括在根治性膀胱切除术前使用度伐利尤单抗联合吉西他滨和顺铂作为新辅助治疗,随后在术后使用度伐利尤单抗单药作为辅助治疗。

This indication is specifically for adult patients diagnosed with MIBC..

该适应症专用于确诊为MIBC的成年患者。

The combination therapy aims to address the needs of patients undergoing radical cystectomy, a surgical procedure commonly performed to treat advanced bladder cancer. The neoadjuvant phase includes administering Durvalumab alongside gemcitabine and cisplatin prior to surgery, while the adjuvant phase involves continued treatment with Durvalumab alone following the procedure.

该联合疗法旨在满足接受根治性膀胱切除术的患者需求,这是一种常用于治疗晚期膀胱癌的手术。新辅助阶段包括在手术前给予度伐利尤单抗(Durvalumab)联合吉西他滨和顺铂,而辅助阶段则涉及术后单独继续使用度伐利尤单抗进行治疗。

This approval marks a significant regulatory milestone for AstraZeneca in expanding therapeutic options for individuals affected by this condition..

这一批准标志着阿斯利康在为受此疾病影响的个体扩展治疗选择方面迈出了重要的监管里程碑。