Posted by Michael Wonder on 10 Sep 2025
Greenwich LifeSciences’ GLSI-100 granted US FDA fast track designation
10 September 2025 - Greenwich LifeSciences today announced that FDA has granted fast track designation for GLSI-100 in the HLA-A*02 patient population.
In the prospective, randomised, single-blinded, placebo-controlled, multi-centre (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone.
