Celldex's Rindopepimut (Rintega(R)) Receives FDA Breakthrough Therapy Designation for the Treatment of Adult Patients with EGFRvIII-positive Glioblastoma
HAMPTON, N.J., Feb. 23, 2015 -- Celldex Therapeutics, Inc. (CLDX) today announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega(R)) Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma (GBM).
This application was based on data from the Phase 2 ReACT study in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM and additional supportive Phase 2 studies. An international Phase 3 study of rindopepimut, called ACT IV, in newly diagnosed GBM completed enrollment (n=745) in December of 2014.
- Published: 23 February 2015
- Written by Editor