Celldex’s investigational immunotherapy rindopepimut received Breakthrough Therapy Designation from the FDA
Celldex Therapeutics, headquartered in Hampton, New Jersey announced on February 23 that the US Food and Drug Administration (FDA) has granted its rindopepimut Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive (epidermal growth factor receptor variant III-positive) glioblastoma (GBM). The FDA’s decision is based largely on data from several Phase II clinical trials involving newly diagnosed or recurrent EGFRvIII-positive GBM. Across all phase II studies, rindopepimut prolonged overall survival well beyond what has been observed in the corresponding patient populations historically, marking an important milestone for this difficult to treat disease. And importantly, these studies also demonstrate that rendopepimut is well tolerated in patients.
Rindopepimut is an investigational immunotherapeutic vaccine that targets EGFRvIII. EGFRvIII is a mutated form of the epidermal growth factor receptor (EGFR) that is only expressed in cancer cells and the expression of this form of EGFR promotes cancer growth. EGFRvIII is present in about 25-40% of GBM tumors and EGFRvIII-positive GBM is typically associated with poor prognosis than the overall GBM population.
According to Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics, Glioblastoma patients have extremely limited treatment options, with only three new drugs approved in more than twenty years. The FDA’s decision to grant Breakthrough Designation underscores rindopepimut’s therapeutic potential, and brings new hope to patients with glioblastoma.