FDA Grants Breakthrough Device Designation to Alpha DaRT for Recurrent Glioblastoma Multiforme

Alpha DaRT, an intraumoral conformal alpha-irradiation strategy, has been granted a second breakthrough device designation by the FDA.

The FDA has granted breakthrough device designation to Alpha Diffusing Alpha-emitters Radiation Therapy (DaRT) for the treatment of patients with recurrent glioblastoma multiforme (GBM), according to a press release issued by Alpha Tau Medical.1

The use of Alpha DaRT involves the insertion of radium-224 impregnated sources into the tumor. The therapy allows highly potent and conformal alpha-irradiation of solid tumors. Alpha DaRT has also been shown to treat the cancerous site without impacting the healthy tissue around it. The therapy’s BTD in GBM marks the second designation from the FDA. Previously, the FDA granted BTD to Alpha DaRT for the treatment of squamous cell carcinoma of the skin and oral cavity without a curative standard of care.1,2

"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 United States and across the world, and to bring new hope for GBM patients," said Uzi Sofer, chief executive officer, Alpha Tau.

In a preclinical study of DaRT for the treatment of solid tumors, investigators hypothesized that administration of aggressive in situ tumor ablation can release tumor antigens and danger signals to achieve anti-tumor T cell responses. In turn, cancer cells may be destroyed along with primary and distant metastases. The study showed that when DaRT is applied with chemotherapy and immunostimulatory agents, it may offer benefit for subjects with solid metastatic tumors.3

Other key findings from the preclinical research are that DaRT prolongs the life expectancy of treated subjects in comparison with surgery, changes the development of memory immunity response against the tumor cells to provide better control than surgery and that combining the therapy with an immune adjuvant can further augment anti-tumor immunity.

With a BTD from the FDA, the development of Alpha DaRT, and the FDA application review process for the therapy will be accelerated. The FDA awards this designation to therapies that appear to be more beneficial to patients than the current standard of care, based on research end points like efficacy, safety, and quality of life.


1. Alpha Tau receives FDA's breakthrough device designation for the treatment of recurrent GBM. New release. Alpha Tau Medical. Ocotber 8, 2021. Accessed October 8, 2021. https://prn.to/3DovKG9

2. Alpha Tau receives breakthrough device designation from the FDA for Alpha DaRT™. New release. Alpha Tau Medical. June 8, 2021. Accessed October 8, 2021. https://bit.ly/3uVsEqb

3. Keisari Y, Hochman I, Confino H, et al. Activation of local and systemic anti‑tumor immune responses by ablation of solid tumors with intratumoral electrochemical or alpha radiation treatments. Cancer Immunol Immunother. 2014; 63:1-9. doi: 10.1007/s00262-013-1462-2