Genta Incorporated (GETA.OB) Announces Agreement With FDA on Special Protocol Assessment of Phase 3 Trial of Tesetaxel as Initial Chemotherapy for Women With Metastatic Breast Cancer
6/18/2012 9:34:20 AM
BERKELEY HEIGHTS, N.J. , June 18, 2012 (GLOBE NEWSWIRE) -- Genta Incorporated (GNTA) announced today that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the Company's proposed Phase 3 trial of oral tesetaxel as initial chemotherapy for women with metastatic breast cancer. The SPA provides FDA agreement that the study design and planned analysis of this Phase 3 trial adequately address objectives necessary to support a regulatory submission. The Company also announced review completion and positive Scientific Advice on the same trial design from the European Medicines Agency (EMA).