FDA批准淋巴瘤试验后加拉帕戈斯群岛收益

Galapagos (NASDAQ:GLPG) shares traded higher in Europe on Friday after the U.S. Food and Drug Administration (FDA) greenlighted a Phase 1/2 trial for its CAR-T cell therapy, GLPG5101, in non-Hodgkin lymphoma, a cancer of white blood cells.

Named ATALANTA-1, the multicenter trial is already underway in Europe, and its early data have indicated GLPG5101’s potential in relapsed/refractory non-Hodgkin lymphoma (NHL), the Belgian biotech said. With the FDA clearance, the company can expand it in the U.S.

Phase 1 of ATALANTA-1 is designed to evaluate GLPG5101’s efficacy and safety to help investigators determine the recommended dose for the Phase 2 section.

Phase 2 is designed to specify the objective response rate, a critical parameter for cancer drugs, as its primary objective. Its secondary objectives include overall survival, the “gold standard” for measuring the clinical benefits of a cancer therapy.