The FDA has rejected a radiopharmaceutical therapy from ITM Isotope Technologies Munich that was positioned to compete with Novartis’ leading treatments in the space.
The agency issued a complete response letter for ITM-11, also known as 177Lu-edotreotide, saying it cannot approve the new drug application in its current form, according to an Aug. 10 news release. The FDA cited chemistry, manufacturing and controls issues as well as items related to a third-party commercial facility, but raised no concerns about the drug’s clinical data or safety profile.
ITM-11 targets gastroenteropancreatic neuroendocrine tumors, a rare cancer of the pancreas, stomach, small intestine and other parts of the gastrointestinal system. The therapy was designed to challenge Novartis’ Lutathera, one of two radioligand therapies the company sells for the same tumor type.
In a phase 3 trial, patients with early-stage disease who received ITM-11 went a median of 23.9 months without tumor growth, compared with 14.1 months for patients on everolimus, an existing treatment.
ITM said it is reviewing the FDA’s feedback and plans to resubmit the application.
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