FDA grants breakthrough designation to Alpha Tau’s device for GBM
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FDA grants breakthrough designation to Alpha Tau’s device for GBM treatment

11 Oct 2021 (Last Updated October 11th, 2021 12:51)

Alpha DaRT also received breakthrough device designation to treat skin cancer in June.

FDA grants breakthrough designation to Alpha Tau’s device for GBM treatment
Glioblastoma multiforme is considered an aggressive malignant brain tumour. Credit: Robina Weermeijer / Unsplash.

The US Food and Drug Administration (FDA) has granted breakthrough device designation to Alpha Tau’s alpha-radiation cancer therapy to treat patients suffering from recurrent glioblastoma multiforme (GBM).

Enabling conformal alpha-irradiation of solid tumours, the Alpha Diffusing Alpha-emitters Radiation Therapy (DaRT) works with the insertion of radium-224 impregnated sources intratumorally.

Short-lived daughters, which are released from the source with the decay of radium, scatter while emitting high-energy alpha particles, allowing them to subsequently kill the tumour.

Given that the alpha-emitting atoms get diffused at a short distance, Alpha DaRT targets only the tumour without impacting the surrounding healthy tissues.

With the latest FDA breakthrough status, Alpha DaRT can be used in treating recurrent GBM as an adjunct to standard medical treatments or as a standalone therapy when no other standard medical therapies are working.

Alpha Tau CEO Uzi Sofer said: “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 centres in the US 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.”

With an average five-year survival rate of below 10%, GBM is considered an aggressive malignant brain tumour.

Alpha Tau is an Israeli medical device company established in 2016 that develops and markets Alpha DaRT to treat solid tumours.

In June, Alpha DaRT secured breakthrough device status to treat squamous cell carcinoma of the skin and oral cavity that does not have a curative standard of care.