Offering a New Option for Head and Neck Cancer Treatment
HekaBio K.K. has announced that Japan has granted regulatory approval for Alpha DaRT Diffusing Alpha Radiation Therapy, a novel solid tumor treatment developed by Alpha Tau Medical Ltd.. Acting as the Designated Marketing Authorization Holder, HekaBio led the approval process and will oversee commercialization of the device in Japan. With this decision, Japan becomes the first country outside Israel to authorize the therapy. The treatment is approved for patients with unresectable locally advanced or recurrent head and neck cancer, offering a new option for individuals who have not responded adequately to existing standards of care. The company also acknowledged the contributions of Dr. Jun Itami, who participated in the clinical study while at the National Cancer Center Hospital and now serves as Director of the High Precision Radiation Therapy Center at Shin Matsudo Central General Hospital, along with the many clinicians who supported the review process.
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Alpha DaRT works by placing small sources containing Radium 224 directly into the tumor using a medical grade stainless steel applicator. As the isotope breaks down, it releases short lived decay products within the tumor tissue that emit alpha particles. These high energy particles cause double strand breaks in the DNA of cancer cells, leading to tumor cell death. Because alpha particles travel only a very short distance, the radiation remains concentrated within the tumor, limiting exposure to surrounding healthy tissue. This localized approach allows physicians to deliver potent radiation without systemic drug therapy and addresses the long standing challenge of harnessing alpha radiation in a controlled and targeted way.
Dr. Jun Itami, Director of the High Precision Radiation Therapy Center at Shin Matsudo Central General Hospital, said the domestic clinical trial results indicate that Alpha DaRT shows meaningful promise for patients whose cancers do not respond to conventional treatments. He explained that successfully applying intratumoral alpha particle therapy in a practical clinical setting marks an important step forward. According to Dr. Itami, the data demonstrating safety and effectiveness provide reassurance for real world use and help guide future research aimed at expanding indications. He added that offering an additional therapeutic option can also provide emotional reassurance to patients and their families. While he noted that continued evaluation and long term follow up remain important, he described the approval as a significant move toward wider clinical adoption.
Uzi Sofer, Chief Executive Officer of Alpha Tau Medical, said receiving marketing authorization in Japan represents a major milestone for both the company and the Alpha DaRT platform. He pointed out that Japan is the first market outside Israel to grant approval and emphasized the country’s strong expertise in head and neck oncology. He expressed appreciation to HekaBio and to the Japanese medical societies that supported the process. Sofer stated that the company plans to work closely with clinicians in Japan to complete post marketing surveillance studies and gather further clinical data in patients with locally advanced or recurrent disease. He also indicated that discussions with the Ministry of Health, Labour and Welfare regarding reimbursement are expected to begin soon and that the company intends to explore additional clinical studies in Japan across other tumor types.
Robert E. Claar, Chief Executive Officer of HekaBio K.K., said the Alpha DaRT program has been a central focus for his team for seven years and described the approval as an important achievement for patients in Japan. He acknowledged the steady backing from healthcare professionals, regulators, and government authorities throughout the development and review process. Claar noted that it is uncommon for Japan to approve a new category medical device originating overseas before the United States and Europe, and he expressed gratitude to all partners involved. He added that the company is preparing for launch with the goal of delivering meaningful clinical benefit and renewed hope to patients facing difficult to treat cancers.
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