Winship Cancer Institute of Emory University

FDA Approves Alpha Tau's IDE for Alpha DaRT Study in Immunocompromised cSCC Patients

- Alpha Tau Medical's Investigational Device Exemption (IDE) has been approved by the FDA for a multi-center study of Alpha DaRT in immunocompromised patients with recurrent cutaneous Squamous Cell Carcinoma (cSCC). - The study, led by Emory University's Winship Cancer Institute, will enroll up to 28 patients across 8 U.S. institutions, focusing on those with weakened immune systems, excluding diabetes. - The primary objective is to determine the objective response rate (ORR), while secondary objectives include progression-free survival, overall survival, local control, and safety assessment. - This trial aims to provide a potential new treatment option for a vulnerable population with limited options, addressing the increased risk of cSCC in immunocompromised individuals.