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Alpha DaRT for Recurrent Head & Neck Cancer Seeks Pre-Market Approval from Japanese PMDA

Monday, November 20, 2023

Alpha Tau Medical and HekaBio K.K. have jointly announced the acceptance of their submission for shonin pre-market approval of Alpha DaRT™ by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The submission is in relation to the treatment of recurrent head and neck cancer patients. The approval request follows a series of pre-submission consultation meetings with the PMDA and is grounded in the successful clinical trial outcomes in Japan, where Alpha DaRT demonstrated safety and efficacy beyond the targeted endpoints for recurrent head and neck cancer.

This approval covers various solid tumor types, including squamous cell carcinoma, basal cell carcinoma, and melanoma, all occurring after prior radiation treatment. With over 10,000 new cases of head and neck cancers reported annually in Japan, Alpha Tau Medical and HekaBio K.K. are actively engaged in discussions with leading biopharmaceutical companies for potential long-term commercial partnerships in Japan, extending beyond the current indication to future applications.

Alpha DaRT, or Diffusing Alpha-emitters Radiation Therapy, is a specialized treatment designed for precise and potent alpha-irradiation of solid tumors. It achieves this by intratumoral delivery of radium-224 impregnated sources. The therapy aims to destroy tumors by releasing short-lived daughters from the sources, dispersing them while emitting high-energy alpha particles. Alpha DaRT's targeted approach seeks to minimize impact on healthy surrounding tissue due to the short diffusion distance of alpha-emitting atoms.