UroGen今日宣布,UGN-102膀胱灌注液的ENVISION临床试验结果显示,接受UGN-102治疗的低级别中等风险非肌层浸润性膀胱癌(LG-IR-NMIBC)患者,完成三个月的治疗后可完全缓解(CR),并且这些患者在一年后的癌症无进展生存率为82.%。 膀胱癌 膀胱癌是泌尿系统最常见的恶性肿瘤,严重威胁人类健康。在全球范围内,它分别是男性...
UGN-102已在美提交新药申请 UroGen Pharma Ltd.近日宣布已完成其在研疗法UGN-102(mitomycin,丝裂霉素)膀胱内溶液的新药申请(NDA),用以治疗低级别中等风险非肌层浸润性膀胱癌(LG-IR-NMIBC)患者。如果美国FDA接受该NDA并授予优先审评资格,Ur...
临床表现以无痛性血尿为主。 根据2b OPTIMA II期研究的最终结果(NCT03558503),研究药物 UGN-102 (mitomycin,丝裂霉素) 治疗低级别中风险非肌层浸润性膀胱癌(NMIBC)患者显示出持久的反应。 缓解持续时间(DOR)为72.5%,研究中未达到中位DOR。63例接受UGN-102的患者完全缓解率为65%。开始治疗后3个月观察到反应。
UroGen Pharma Ltd.近日宣布已完成其在研疗法UGN-102(mitomycin,丝裂霉素)膀胱内溶液的新药申请(NDA),用以治疗低级别中等风险非肌层浸润性膀胱癌(LG-IR-NMIBC)患者。如果美国FDA接受该NDA并授予优先审评资格,UroGen预计UGN-102可能在2025年初获美国FDA批准。 根据新闻稿,该疗法有潜力成为首个获得批准的低级别中等...
根据2b OPTIMA II期研究的最终结果(NCT03558503),研究药物 UGN-102 (mitomycin,丝裂霉素) 治疗低级别中风险非肌层浸润性膀胱癌(NMIBC)患者显示出持久的反应。 缓解持续时间(DOR)为72.5%,研究中未达到中位DOR。63例接受UGN-102的患者完全缓解率为65%。开始治疗后3个月观察到反应。基于这些发现,计划在2020年底启...
The phase 3 ENVISION study investigating UGN-102 previously met its primary end point of complete response rate. Bladder cancer, light micrograph, photo under microscope: ©Dr_Microbe - stock.adobe.com The investigational drug UGN-102 (mitomycin) demonstrated a 12-month duration of respons...
Treatment with UGN-102 (mitomycin) elicited a high complete response (CR) rate at 3 months in patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC) and increased their likelihood of remaining disease free 1 year later, according to f...
Treatment with UGN-102 (mitomycin) with or without transurethral resection of bladder tumors (TURBT) led to an improvement in disease-free survival (DFS) compared with TURBT alone in patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer (NMIBC), meeting the primary end...
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) for intravesical solution as a chemoablative therapy in patients with LG...
Purpose: Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumor under general anesthesia. We evaluated the efficacy and safety of UGN-102, a mitomycin-containing reverse thermal gel, as a ...