Innovent receives fast track designation from the US FDA for IBI343 (TOPO1i anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer

Innovent Biologics

12 June 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its TOPO1i anti-CLDN18.2 ADC (IBI343) for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma that has relapsed and/or is refractory to one prior line of therapy. 

Previously, IBI343 has already received FDA approval of its IND application for the treatment of pancreatic ductal adenocarcinoma.

Read Innovent Biologics press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track