ISNES, Belgium, July 26, 2022 (GLOBE NEWSWIRE) -- ERC Belgium S.A. (ERC), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sitoiganap (Gliovac or ERC1671/SITOIGANAP) ERC's cell-based immunotherapy for the treatment of glioblastoma, the most aggressive form of brain cancer. Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical needs. The purpose is to get important new drugs to the patient earlier. The FDA stated, That Sitoiganap, combined with GM-CSF and cyclophosphamide and bevacizumab, for the treatment of recurrent glioblastoma to improve overall survival meets the criteria for Fast Track designation. Fast Track addresses a broad range of serious conditions.
Apostolos Stathopoulos, M.D., Ph.D., ERC Belgium President and CEO commented, Receiving Fast Track designation from the FDA reinforces ERC's belief that our cell-based immunotherapy for the treatment of serious cancers represent a major breakthrough. We are pleased that the FDA's decision reinforces the observation of improved median overall survival (mOS) in these patients as well as continued improvements in functionality and quality of life in the patients who responded to Sitoiganap treatment. Furthermore, Fast Track makes Sitoiganap eligible for the FDA's Accelerated Approval process and Priority Review.