FDA Breakthrough Device Designation Granted to Alpha DaRT in Recurrent Glioblastoma

The Alpha DaRT system was granted breakthrough device designation by the FDA for the treatment of glioblastoma.

The a-radiation cancer therapy Alpha DaRT, which stands for diffusing a-emitters radiation therapy, was granted breakthrough device designation for the treatment of patient with recurrent glioblastoma multiforme (GBM), according to the drug’s developer, Alpha Tau Medical.

The designation is for adjunctive use alongside standard of care therapies or alone in patients who have no other alternative treatment options.

“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 patient,” said Alpha Tau CEO, Uzi Sofer. “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. This is fantastic news for Alpha Tau and fantastic news for so many GBM patients around the world.”

The system works by delivering highly potent radium-224 impregnated sources intratumorally. Short-lived daughters are released from the source of decaying radium and are dispersed throughout the body emitting a-particles to the tumor.

This designation was granted based on preliminary evidence that Alpha DaRT will provide more efficacy in this population versus current standard of care options and will allow for an expedited review process and facilitate the development of clinical trials.

This designation by the FDA follows another breakthrough device designation granted by the agency to Alpha DaRT in June 2021 for the treatment of patients with skin cancer who cannot undergo treatment for curative intent.

Research in human subjects using Alpha DaRT has been conducted in head and neck and skin cancers, revealing a tolerable safety profile and significant tumor responses.

In a prospective first-in-human trial of 31 lesions in 28 patients with recurrent squamous cancers of the skin and head and neck who were previously treated with either surgery or radiation, 22 lesions (78.6%) showed a complete response to treatment and 6 (21.4%) demonstrated a partial response. Acute toxicity included swelling and mild skin ulceration following local pain and erythema at the implantation site. Of note, pain and grade 2 skin ulceration was resolved in 90% of patients between weeks 3 and 5 following treatment.2


  1. Alpha Tau Receives FDA's Breakthrough Device Designation for the Treatment of Recurrent GBM. News release. Alpha Tau Medical. October 8, 2021. Accessed October 8, 2021. https://bit.ly/2YxMWtP
  2. Popovtzer A, Rosenfeld E, Mizrachi A, et al. Initial safety and tumor control results from a “first-in-human” multicenter prospective trial evaluating a novel alpha-emitting radionuclide for the treatment of locally advanced recurrent squamous cell carcinomas of the skin and head and neck. Int J Radiat Oncol Biol Phys. 2020;106(3):571-578. doi:10.1016/j.ijrobp.2019.10.048
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