On November 20, 2023 Alpha Tau Medical Ltd. ("Alpha Tau") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, and HekaBio K.K. ("HekaBio") a Japan-based healthcare investment, development and commercialization platform which is partnered with Alpha Tau, reported that Japan’s Pharmaceuticals and Medical Devices Agency ("PMDA") has accepted Alpha Tau’s submission requesting shonin pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer, following multiple pre-submission consultation meetings with the PMDA per common practice in Japan (Press release, Alpha Tau Medical, NOV 20, 2023, View Source [SID1234637826]). This submission is based upon Alpha DaRT’s clinical trial results in Japan which exceeded the target endpoints for safety and efficacy in patients with recurrent head and neck cancer.
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The head and neck cancer indication includes all solid tumor cancer types after prior radiation treatment, including squamous cell carcinoma, basal cell carcinoma, and melanoma. According to the most recent registry of the Japan Society of Head & Neck Cancer, there are more than 10,000 new cases of head and neck cancers in Japan each year. Alpha Tau and HekaBio are in advanced discussions with a number of large biopharmaceutical companies regarding a potential long-term commercial partnership in Japan for this and future indications.
Uzi Sofer, CEO of Alpha Tau, noted, "We identified Japan as an important strategic market and initiated a local clinical trial early on in our clinical development, and we are excited that this trial has not only met but exceeded its endpoints. We are working on all necessary preparations ahead of potential approval and commercialization, while continually considering other indications for initiating clinical trial investigation in Japan based on the specific patient needs there."
Rob Claar, CEO of HekaBio, added, "I am pleased that following the successful completion of the clinical trial and collaborative consultations to date, the PMDA has accepted our submission. In light of the relatively high mortality rate and significant morbidities associated with existing treatments in head & neck cancer, we are excited about the potential to bring a new alternative to the Japanese market. We continue to work with Alpha Tau to find the best commercial partner for the Japanese market, in order to be prepared for launch as quickly as possible."