Innovent Gets FDA's Fast Track Designation For IBI343 As Monotherapy For Advanced Pancreatic Cancer

(RTTNews) - Innovent Biologics Inc. said that the U.S. Food and Drug Administration has granted Fast Track Designation to its TOPO1i anti-CLDN18.2 ADC, 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.

At the ASCO 2024 Annual Meeting, Innovent reported the preliminary Phase 1 results of IBI343 in advanced pancreatic ductal adenocarcinoma patients who have received at least one prior line of treatment. In the 6 mg/kg dose group, among the 10 evaluable PDAC patients with CLDN18.2 1/2/3+greater than or equal to 60%, the overall response rate was 40%.

Fast Track Designation is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain Fast Track Designation qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug.

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