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# Greenwich Gets Fast Track for Breast Cancer Therapy
- URL: https://www.fdaweb.com/greenwich-gets-fast-track-for-breast-cancer-therapy/
- Published: 2025-09-10T12:00:00.000Z
- Updated: 2026-09-14T15:21:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159844

FDA has granted Greenwich LifeSciences fast track status for GLSI-100, an investigational immunotherapy aimed at preventing breast cancer recurrences. The designation applies to HLA-A\*02-genotype patients with HER2-positive breast cancer who have completed standard HER2-targeted therapy.

The company says GLSI-100 has already shown promise in earlier studies. In a Phase 2b trial involving HER2-positive breast cancer patients, the treatment reduced metastatic recurrences by 80% or more over five years compared with placebo. The therapy was well tolerated, with no serious adverse events reported, it says.

The ongoing Phase 3 FLAMINGO-01 study, led by Baylor College of Medicine, is enrolling up to 750 patients globally to further evaluate GLSI-100’s safety and efficacy, according to the company.