FDA Grants Breakthrough Designation to AlphaMedix for Advanced Neuroendocrine Tumor Treatment

The FDA has granted breakthrough therapy designation to AlphaMedixTM (212Pb-DOTAMTATE) for treating adults with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), marking it as the first targeted alpha therapy to receive this status. While this therapy is not yet FDA-approved, the breakthrough therapy designation allows for expedited development and review of promising therapies. The designation is based on positive outcomes from phase 1 and ongoing phase 2 trials, showing the treatment’s safety and efficacy, including a notable overall response rate and manageable side effects. AlphaMedix is a targeted alpha emitter that delivers radiation to tumors with minimal damage to surrounding tissue and is currently in phase 2 development. The FDA’s designation highlights AlphaMedix’s potential as an effective treatment option for patients with metastatic or inoperable somatostatin receptor-expressing GEP-NETs, aiming to offer benefits over existing therapies and underscoring a significant advance in the field of neuroendocrine cancer treatment. Read the press release here, and learn more about the clinical trial here.