Alpha Tau Medical, the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, is pleased to announce that it has received Breakthrough Device Designation for Alpha DaRT from the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent glioblastoma multiforme (GBM). This is the second Breakthrough Device Designation that Alpha Tau has received from the FDA, following its announcement on June 8, 2021 of the receipt of the designation for the treatment of skin cancer without curative standard of cure.
GBM is an aggressive malignant brain tumor, with an average 5-year survival rate of less than 10%, and is the most common malignant tumor of the brain or central nervous system. According to the designation, Alpha DaRT is proposed for use in treating recurrent GBM as an adjunct to standard medical therapies or as a standalone therapy after standard medical therapies have been exhausted.
“As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA’s Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world, and to bring new hope for GBM patients. I am very proud of our team and our collaborators who have worked hard to extend the use of Alpha DaRT to GBM and have already accomplished so many amazing things,” said Alpha Tau CEO Uzi Sofer. “This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world.”