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FDA grants breakthrough therapy designation to Rintega for EGFRvIII-positive glioblastoma
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The FDA today granted breakthrough therapy designation to rindopepimut for the treatment of adults with epidermal growth factor receptor variant III-positive glioblastoma, according to a press release from the drug’s manufacturer.
Rindopepimut (Rintega, Celldex Therapeutics) is an investigational immunotherapy designed to target EGFRvIII, a tumor-specific oncogene.
“The FDA’s decision to grant breakthrough designation underscores rindopepimut’s therapeutic potential for patients with glioblastoma,” Anthony Marucci, co-founder, president and CEO of Celldex Therapeutics, said in a press release. “These patients have extremely limited treatment options, with only three new drugs approved in more than 20 years. Emerging clinical data suggests that rindopepimut may offer an improvement over existing standard of care for EGFRvIII-positive patients. With continued positive data, we look forward to working closely with the FDA to support potential approval of rindopepimut as expeditiously as possible.”
The FDA based its decision on results from the phase 2 ReACT study in recurrent glioblastoma, the phase 2 ACT III study in newly diagnosed glioblastoma and additional supportive phase 2 studies.
The ACT IV international phase 3 study, which is evaluating rindopepimut in newly diagnosed glioblastoma, completed enrollment (n = 745) in December.