The U.S. Food and Drug Administration has granted breakthrough therapy designation to Rintega (rindopepimut) for the treatment of adult patients with EGFRvIII-positive glioblastoma. Rintega is an investigational immunotherapy that targets the tumor-specific oncogene EGFRvIII-the functional and permanently activated variant of the epidermal growth factor.
Research has shown that EGFRvIII is the most common EGFR mutant for glioblastoma multiforme tumors.
The breakthrough therapy designation, enacted as part of the FDA's 2012 Safety and Innovation Act, was created to expedite the development and review time of a potential new drug for serious or life-threatening disease where early clinical evidence suggests the drug may demonstrate substantial improvement compared with existing therapies.
Rintega's application is based on three completed Phase II trials of Rintega-ACTIVATE, ACT II, and ACT III-in patients with newly diagnosed EGFRvIII-positive glioblastoma. Those trials showed consistent improvements in both overall survival and median progression-free survival, notes a news release from the drug's manufacturer, Celldex Therapeutics, Inc.
Additionally, an international Phase III study of Rintega, ACT IV, in 745 patients with newly diagnosed glioblastoma is ongoing after having completed enrollment in December. And Rintega is also being studied in the Phase II ReACT study in patients with recurrent glioblastoma.