Greenwich LifeSciences announced that the European Medicines Agency has approved the use of its commercially manufactured GP2 in the Phase III FLAMINGO-01 breast cancer trial. The same commercial lot of GP2 vials was already approved by the FDA for US sites earlier in 2026, and all approximately 40 to 50 US sites have been supplied and are treating patients. With the EMA decision, all clinical sites in the US and Europe, now totaling approximately 170 to 180 sites, are expected to use the same lot, and shipments to European pharmacies are already under way. The company is also seeking approval to use this lot in the UK and Canada through separate regulatory processes. The open-label non-HLA-A*02 arm of the trial is fully enrolled with 250 patients, and preliminary data shows an approximately 70 to 80 percent reduction in recurrence rate after the primary immunization series, trending similarly to the Phase IIb results where treated HLA-A*02 patients saw up to an 80 percent reduction.
Greenwich Lifesciences IncEuropean approval allows use of commercial GP2 in FLAMINGO-01 trial, enabling trial progress and potential market access.