None
EN
STAT+: In surprise decision, FDA rejects radiopharma therapy expected to rival Novartis treatment
['Allison Deangelis', 'Allison Covers What Hot Startups Are Getting Up To', 'Who S Financing Them. She Is Also Co-Host Of The Weekly Biotech Podcast', 'Biotech Startups', 'Venture Capital Reporter', 'Adam Feuerstein', 'Angus Chen', 'Meghana Keshavan', 'Jason Mast', 'Brian Yang']
STAT
The Food and Drug Administration has rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis.
The drug, ITM-11, had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field.
Radiopharmaceuticals are an emerging type of treatment designed to shoot radioactive isotopes directly at tumor cells.
ITM reported in March 2025 that patients with the earliest forms of this cancer who received ITM-11 infusions lived for 23.9 months without their tumors growing.
Meanwhile, patients taking another treatment on the market, everolimus, went a median 14.1 months before their cancer progressed.