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Brain Cancer Vaccine Awarded Orphan Drug Status

doi: 10.1097/01.COT.0000525711.63476.f1
FDA Updates
FDA; brain cancer

FDA; brain cancer

The FDA has awarded orphan drug status to DRU-2017-5947, an immunotherapy drug, for the treatment for glioblastoma.

The vaccine stimulates the immune system to kill tumor cells that contain survivin, a protein that helps cancer cells resist conventional treatments. A phase II study of DRU-2017-5947 given in addition to standard treatment for patients with newly-diagnosed glioblastoma is ongoing at Roswell Park Cancer Institute, Buffalo, N.Y., and four other institutions: Cleveland Clinic, Dana-Farber Cancer Institute, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center.

“We are excited by the results to date and appreciative of this acknowledgement that [DRU-2017-5947] holds promise,” said Robert Fenstermaker, MD, Chair of the Department of Neurosurgery at Roswell Park. “Those of us working to help patients with glioblastoma live longer realize that the gains from existing therapies have been quite limited. We are eager to move this work forward to a larger multicenter randomized study with the momentum provided by the orphan status designation.”

On the strength of an interim analysis of the in-progress phase II study, the investigators expect to pursue late-stage clinical trials with DRU-2017-5947, pending FDA approval.

Wolters Kluwer Health, Inc. All rights reserved.
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