Alpha Tau Medical's Cancer Therapy Device Approved in Japan
Alpha Tau Medical has received marketing approval in Japan for its Alpha DaRT® radiation therapy technology. The approval is for treating unresectable, locally advanced, or recurrent head and neck cancer. This marks the first clinical authorization for the medical device outside of Israel.
- The Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) technology works by inserting seeds coated with radium-224 directly into the tumor. As the radium decays, it releases alpha-emitting daughter atoms that diffuse through the tumor tissue, delivering a highly potent and localized dose of radiation that causes irreparable double-strand DNA breaks in cancer cells. - This approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is significant as it is rare for a foreign-originated medical device to gain authorization in Japan ahead of the U.S. and Europe. The decision was based on a Japanese clinical trial that successfully exceeded its primary endpoints for safety and efficacy. - As a condition of the approval, Alpha Tau will be required to conduct a post-market surveillance study of 66 patients at five Japanese medical centers to further evaluate the real-world safety and performance of the therapy. - The technology's cell-killing mechanism is independent of the tumor's oxygen level, giving it a potential advantage in treating hypoxic tumors which are known to be resistant to conventional gamma radiation therapy. - In the United States, Alpha Tau has received Breakthrough Device Designation from the FDA for using Alpha DaRT to treat recurrent glioblastoma and cutaneous squamous cell carcinoma (cSCC). The company has begun submitting its pre-market approval (PMA) application to the FDA for the cSCC indication. - Beyond head and neck cancer, the company is actively investigating Alpha DaRT for a variety of other solid tumors, with clinical trials underway or planned for pancreatic cancer, lung cancer, prostate cancer, and brain tumors. - Standard treatment for high-risk, recurrent head and neck cancer in Japan often involves chemoradiotherapy, which can have severe toxicities. Annually, there are more than 10,000 new cases of head and neck cancer in the country.
