STAT+: In surprise decision, FDA rejects radiopharma therapy expected to rival Novartis treatment — SkimNews
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- FDA rejected ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing issues as the basis for the refusal.
- ITM-11 was designed to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) by delivering radioactive isotopes directly to tumor cells.
- In March 2025, ITM reported that patients with the earliest forms of GEP-NETs receiving ITM-11 lived 23.9 months without tumor growth, compared to 14.1 months for patients on the existing treatment everolimus.
- The rejection halts ITM-11's path to becoming a competitor to a Novartis radiopharmaceutical therapy already on the market.
- Radiopharmaceuticals are described as an emerging treatment class, making ITM-11 part of a new wave of targeted radioactive cancer therapies.
Why it matters: ITM-11 had shown a roughly 10-month progression-free survival advantage over the existing standard of care everolimus (23.9 vs. 14.1 months), making it a meaningful new option for GEP-NET patients. Because the rejection was driven by manufacturing rather than efficacy, Novartis retains its unchallenged foothold in this radiopharmaceutical niche until ITM resolves the cited deficiencies and refiles.
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