STAT+: In surprise decision, FDA rejects radiopharma therapy expected to rival Novartis treatment
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- FDA rejected ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing issues in what STAT calls a surprise decision
- ITM-11 was designed to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a rare cancer affecting the pancreas, stomach, small intestine, and other parts of the gastrointestinal system
- ITM reported in March 2025 that patients with the earliest forms of GEP-NETs who received ITM-11 infusions lived a median 23.9 months without tumor growth, compared with 14.1 months for patients on the existing treatment everolimus
- Radiopharmaceuticals are an emerging treatment class that delivers radioactive isotopes directly to tumor cells, and the rejection removes a prospective challenger to Novartis's established radiopharma franchise in GEP-NETs
Why it matters: The rejection was driven by manufacturing rather than efficacy concerns, meaning ITM-11's clinical case — a roughly 10-month progression-free survival advantage over everolimus — remains intact pending a manufacturing fix. Novartis retains its uncontested position in the GEP-NET radiopharma space for now, and ITM will need to resolve its production issues before resubmitting.
Ask SkimNews
