信达生物IBI343获得FDA快速通道认证，用于晚期胰腺癌单药治疗-动脉橙

信达生物IBI343获得FDA快速通道认证，用于晚期胰腺癌单药治疗

2024-06-12 RTTNews 等4家媒体报道 FDA动态





Innovent Biologics宣布，FDA授予其TOPO1i抗CLDN18.2 ADC快速通道指定，用于治疗复发或先前治疗难治的晚期胰腺导管腺癌。这种指定有助于临床开发并增加与FDA的沟通，可能会加快批准速度。IBI343在治疗患者中的初步第一阶段结果显示，特定组的总有效率为40%。有关更多健康新闻，请访问rttnews.com。（摘要由动脉网AI生成）

关联公司

 信达生物

2024-06-12 Innovent Gets FDA's Fast Track Designation For IBI343 As Monotherapy For Advanced Pancreatic Cancer

RTTNews
2024-06-12 Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

CISION
2024-06-13 Innovent Receives Fast Track Designation from the U.S. FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

BioSpace
2024-06-13 Innovent Secures Fast Track Status from the FDA for IBI343, a Monotherapy for Advanced Pancreatic Cancer

PHARMA FOCUS ASIA