Alpha Tau’s Alpha DaRT Cancer Radiation Device Gets FDA Breakthrough Designation

Israel-based Alpha Tau Medical has received a second Breakthrough Device designation for its alpha-radiation cancer therapy device Alpha DaRT.

The first breakthrough designation, granted on June 8, covered the treatment of skin cancer, while the new breakthrough status covers the treatment of patients with recurrent glioblastoma multiforme (GBM), an aggressive malignant brain tumor.

GBM, which is the most common malignant tumor of the brain or central nervous system, has an average five-year survival rate of less than 10 percent.

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.