GI Innovation's GI-101A Designated for FDA Fast Track

[Financial News] GI Innovation said on the 26th that its immuno-oncology drug candidate GI-101A had received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of a treatment for metastatic urothelial cancer. The company said the FDA designated GI-101A as a Fast Track program for patients with locally advanced or metastatic urothelial cancer who had previously received immuno-oncology treatment.
The FDA Fast Track program supports the development of drug candidates for serious, life-threatening diseases that may offer advantages over existing treatments. Once designated, developers can work more closely with the FDA during development. If sufficient clinical data are secured, additional expedited review pathways such as priority review or accelerated approval may also be available.
GI-101A is being developed in combination with Keytruda. According to the company, an early-stage result from a Phase 1 trial of the combination therapy showed an objective response rate (ORR) of 50% and a disease control rate (DCR) of 75% in four patients with advanced or metastatic urothelial cancer who had prior experience with immuno-oncology treatment. The findings were presented orally at the 2026 American Society of Clinical Oncology (ASCO) meeting.
In particular, urothelial cancer that has failed immuno-oncology treatment is considered an area with limited treatment options. The company said responses have continued even after the ASCO presentation, and that the patients who showed partial response (PR) have remained on treatment for more than two years and more than seven months, respectively.
GI Innovation is currently conducting a randomized Phase 2 trial of the GI-101A and Keytruda combination therapy. Since the first patient was dosed in May, patient enrollment has also been underway.
Jang Myung-ho, CEO of GI Innovation, said, "While the FDA decides whether to grant Fast Track designation within 60 days of accepting an application, GI-101A received the designation in just two weeks, which is very encouraging." He added, "With this designation as a springboard, we will accelerate clinical development so that we can overcome the limits of existing treatments and offer new treatment opportunities to more patients."

[email protected] Kang Jung-mo Reporter