STAT+: New radiopharmaceutical heading to the FDA after Phase 3 win
ITM, a pioneer in radiopharmaceuticals, said it will submit its first drug for approval after reporting the therapy halted tumor progression for nearly two years.
A pioneer in radiopharmaceuticals said Thursday that it will submit its first drug for approval after reporting the therapy halted tumor progression for nearly two years.
The drug from ITM Isotope Technologies Munich SE has been developed as a treatment for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. These rare cancers grow in the pancreas, stomach, small intestine, and other parts of the gastrointestinal system.
In a Phase 3 trial, patients with the earliest forms of this cancer who took the drug, called ITM-11, lived for 23.9 months without their tumors growing, the company reported. Meanwhile, patients taking another treatment on the market, everolimus, went a median 14.1 months before their cancer progressed.
