FDA Turns Down a Radiopharmaceutical Cancer Therapy on Manufacturing Grounds, Not on Whether It Works

ITM Isotope Technologies Munich said it received a Complete Response Letter on August 7 for 177Lu-dotatate, known as ITM-11, an agent developed for gastroenteropancreatic neuroendocrine tumors. For patients with neuroendocrine tumors and the families researching options for them, that distinction is the whole story. Inside a Complete Response LetterA Complete Response Letter is the FDA's formal notice at the end of a review cycle that an application cannot be approved as submitted. It issued a Complete Response Letter for ITM-11, meaning the application cannot be approved as submitted. Existing approved therapies for neuroendocrine tumors remain available.