FDA issues complete response letter rejecting ITM’s neuroendocrine tumor drug over manufacturing concerns

The U.S. Food and Drug Administration sent a complete response letter to ITM Isotopes Technologies, refusing approval of its lead candidate for gastroenteropancreatic neuroendocrine tumors because of deficiencies in the drug’s chemistry, manufacturing and controls.

The decision did not question the clinical or safety data from the phase‑3 Compete trial, which showed the agent, ITM‑11, extended progression‑free survival compared with Novartis’ Afinitor, although it did not achieve a statistically significant improvement in overall survival.

ITM’s chief executive, Andrew Cavey, M.D., said the company remains confident in the therapeutic potential of ITM‑11 and will work closely with the FDA and its manufacturing partners to resolve the identified issues.

The FDA’s concerns focus on the manufacturing process at a third‑party commercial facility, prompting the company to revise its chemistry, manufacturing and controls documentation before resubmission.