Radiopharmaceutical biotech firm Isotope Technologies Munich (ITM) has secured fast-track designation from the U.S. Food and Drug Administration (FDA) for its kidney cancer diagnostic/therapeutic agent.
ITM-94 is a gallium-68-radiolabeled PET imaging agent. Along with the radiotherapeutic compound ITM-91 (Lu-177 Lu-DPI-4452), the two make up a peptide-based theranostic pair, which targets carbonic anhydrase IX, a cell surface protein that plays a key role in the tumor microenvironment, the company said.
Both are being evaluated in a clinical trial that will assess their safety, tolerability, imaging characteristics, and efficacy in patients with unresectable, locally advanced, or metastatic solid tumors, according to ITM.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
