Alpha Tau gets FDA 'breakthrough' nod for brain tumor rad therapy

By staff writers

October 8, 2021 -- Alpha Tau Medical recently received a breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its Alpha DaRT treatment.

Alpha DaRT is intended to treat patients with recurrent glioblastoma multiforme, an aggressive malignant brain tumor with an average five-year survival rate of less than 10%.

The treatment irradiates solid tumors with alpha rays, the company said, and it is delivered by intratumoral insertion of sources impregnated with radium-224. When the radium decays, its short-lived daughters are released from the source and disperse while emitting high-energy alpha particles that destroy the tumor.

Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT mainly affects the tumor, sparing the healthy tissue around it, the company said.

This is the second such designation that Alpha Tau has received from the FDA, following its receipt of the designation in June for treating skin cancer.

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