Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer
Shots:
- The NMPA has granted BTD to IBI343 alone for treating CLDN18.2+ advanced pancreatic ductal adenocarcinoma (PDAC) progressed post 1L of systematic therapy
- Designation was based on the ongoing P-I trial of IBI343 (6mg/kg, Q3W) in CLDN18.2+ advanced PDAC patients (n=43) treated with at least 1L of therapy (5% received 2L+ of therapy) across China, Australia & the US. It depicted cORR of 23.3%, PFS in 26 pts & mPFS of 5.3mos. at the data cutoff
- IBI343 (CLDN18.2 ADC) is also in P-III study for GC. It previously received the NMPA’s BTD for CLDN18.2+ GC progressed post 2L of therapy & PDAC progressed post 1L of therapy as well as the FDA’s FTD for r/r advanced unresectable/metastatic PDAC
Ref: Innovent | Image: Innovent
Related News:- Innovent Reports the NMPA’s Approval of Dovbleron (Taletrectinib Adipate Capsule) for Treating ROS1-Positive NSCLC
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
