GI Innovation receives FDA Fast Track Designation for GI-101A

GI Innovation has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its immunotherapy candidate, GI-101A. The designation is intended for patients with locally advanced or metastatic urothelial carcinoma who have previously undergone immunotherapy.

In Phase 1 clinical trials involving a combination therapy of GI-101A and Keytruda, the drug demonstrated an objective response rate (ORR) of 50% and a disease control rate (DCR) of 75% in patients who had failed prior immunotherapy. These results were presented at the 2026 American Society of Clinical Oncology (ASCO) meeting.

The FDA's Fast Track status is expected to accelerate the development process through frequent communication with the agency and potential eligibility for Priority Review or Accelerated Approval, which could reduce the drug review period to six months. GI Innovation is currently conducting a randomized Phase 2 clinical trial, with patient enrollment progressing rapidly following the first dose administered in May.